Unveiling Confidence: A Guide to Breast Implants in Dubai
For many, the decision to undergo breast augmentation is deeply personal. It might stem from a desire to achieve a more proportionate figure, restore lost volume after pregnancy or weight loss, or simply enhance natural breast size and shape. Dubai's vibrant medical landscape provides a sophisticated environment where these aesthetic goals can be realized with precision and care.
When considering breast implants in Dubai, it's essential to understand the basics. Breast implants are medical devices placed under the breast tissue or chest muscle to increase breast size and improve shape. They come in various types, primarily distinguished by their filling material: Saline Implants: These are silicone shells filled with sterile salt water. They offer a uniform feel and can be adjusted in volume during surgery.
These are silicone shells filled with sterile salt water. They offer a uniform feel and can be adjusted in volume during surgery. Silicone Implants: These are pre-filled with a silicone gel that closely mimics the feel of natural breast tissue. They are known for their soft, natural feel and are available in various consistencies, including 'gummy bear' implants which are form-stable.
Beyond the filling, implants also vary in shape (round or anatomical/teardrop) and texture (smooth or textured), each offering different aesthetic outcomes. The choice of implant type, size, and shape is a crucial decision made in close consultation with your surgeon, considering your body type, aesthetic goals, and lifestyle.
Dubai's healthcare sector is strictly regulated by the Dubai Health Authority (DHA), ensuring high standards of safety and quality across all medical procedures, including cosmetic surgery. Clinics and surgeons offering breast augmentation must adhere to stringent guidelines, use FDA-approved implants (or equivalent international approvals), and maintain state-of-the-art facilities. This commitment to patient safety provides a reassuring environment for those considering surgery in the emirate.
Breast augmentation surgery is typically performed under general anesthesia and usually takes a few hours. The surgeon makes an incision (commonly in the crease under the breast, around the nipple, or in the armpit) and creates a 'pocket' where the implant will be placed – either above or below the chest muscle. Placing implants under the muscle can sometimes offer a more natural look and feel, especially for slimmer individuals.
After surgery, you can expect some swelling, bruising, and discomfort, which can be managed with prescribed pain medication. A special support bra is typically worn to aid in healing and support the new implants. While most patients feel well enough to return to light activities and desk jobs within a week or two, strenuous activities and heavy lifting should be avoided for several weeks. Full recovery and the settling of the breast shape can take a few months.
It's important to remember that breast implants are not lifetime devices and may require replacement after 10-15 years, though some can last longer. Regular follow-ups with your surgeon are crucial to monitor the implants' condition and address any concerns.
Selecting a qualified and experienced plastic surgeon is paramount to achieving satisfying and safe results. In Dubai, many highly reputable, board-certified plastic surgeons specialize in breast augmentation. When making your choice, consider: Board Certification and Credentials: Ensure your surgeon is certified by a recognized plastic surgery board.
Ensure your surgeon is certified by a recognized plastic surgery board. Experience: Look for a surgeon with extensive experience in breast augmentation procedures.
Look for a surgeon with extensive experience in breast augmentation procedures. Patient Testimonials and Before-and-After Photos: These can provide insights into a surgeon's aesthetic style and patient satisfaction.
These can provide insights into a surgeon's aesthetic style and patient satisfaction. Communication: A good surgeon will listen to your goals, explain the procedure thoroughly, and address all your questions and concerns.
Dubai offers a unique blend of luxury, advanced medical technology, and highly skilled professionals, making it an attractive destination for those considering breast implants. With careful research and a thorough understanding of the process, you can embark on a journey to enhanced confidence and a more fulfilling self-image.
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My favorite beauty products for a budget-friendly glam are all under $25
New York Post may be compensated and/or receive an affiliate commission if you click or buy through our links. Featured pricing is subject to change. With a classic catalog of retinol creams, full-coverage foundations and shampoos to sort through at your favorite retailers, your subtotal can cost a pretty penny before you know it. Though I love those fancy formulas and splurge-worthy skincare items, I've learned — through research and years of product testing — that beauty doesn't necessarily have to break the bank. From best-selling Amazon products (including the retailer's beauty products on everyone's wishlists) to the best concealers and cream blushes you can get your hands on, I rounded up this year's must-have hair, makeup and skincare products — all under $25. In short, these are the products I'd express-order from Amazon if on a deserted island. If I could. Ahead, find the exclusive edit of the buzziest beauty products on the market. Rest assured these are the top products to try next if you want the best of beauty but don't want price tags to get the best of you. Amazon Pros: Sulfate-free, so offers a gentle cleanse Formulated with niacinamide and zinc to help hydrate the hair Cons: Overuse can lead to dry hair, so use every other day if you have fine to medium hair Meet the quiet champion in the drugstore aisle: the Dove Scalp+ Density Boost Hydrating Shampoo. Clocking in at under $12, this sulfate-free formula doesn't just promise healthier hair; it delivers it with clinical precision. Developed by dermatologists, it's part of Dove's Scalp+ Hair Therapy line, a range that speaks to the increasingly loud demand for hair care that treats the scalp with the same care we give our skin. In other words: this isn't just shampoo. Victoria Giardina The brilliance of the formula lies in its skincare-inspired simplicity. Packed with vitamin B3, zinc, peptides and moisture-balancing agents, it goes beyond surface-level cleansing to restore the scalp's ecosystem, which is essential for anyone experiencing thinning, dryness or dullness. After using this shampoo for more than a year, my scalp feels more hydrated and volumized at the roots. It may be a less-than-$25 product, but it's the unsung hero that's playing in the same league as high-end competitors — minus the inflated price tag and overhyped promises. And, let's not forget the ethics. Dove's formula is vegan, PETA-approved and free from sulfates and harsh stripping agents. In a market dominated by greenwashed marketing, that kind of transparency matters. But even if it didn't, the results speak for themselves. Best Conditioner: Aussie Miracle Moist Conditioner Amazon Pros: Helps detangle hair Smooths frizz Great for dry hair Cons: Packaging can be improved In an era where hair care shelves are crowded with $40 conditioners in minimalist bottles promising miracles, Aussie Miracle Moist Conditioner is a *true* miradcle. For less than $10, this drugstore staple delivers what many prestige brands only pretend to: real hydration, softness and manageability. Its formula, enriched with avocado and Australian jojoba oil, is a love letter to thirsty hair. It's not trying to be trendy or niche. It simply works, and the ends of my usually dry hair drink it up. What Aussie understands — and executes flawlessly — is that not everyone wants a 10-step routine to achieve good hair. Miracle Moist is about ease and payoff. It detangles in seconds, smooths frizz and leaves my hair feeling genuinely nourished. It doesn't just coat strands in synthetic silkiness; it revives them. Whether you're dealing with heat damage or dryness, this conditioner consistently shows up and delivers, with a creamy texture and clean-rinsing finish that rivals formulas three times its price. Oh, and it's also cruelty free, paraben-free and dye-free, and yet still somehow feels indulgent. It doesn't compromise results, which makes this a must-have in anyone's haircare routine. The miracles don't end here. You can score both the shampoo and conditioner for $15 on Amazon. Best Face Wash: Elizabeth Arden Eight Hour HydraPlay 2-in-1 Daily Cleanser Amazon Pros: Doubles as a face mask due to its creamy formula Helps mitigate the appearance of pores Absorbs well and creates a wonderful base for other skincare products or makeup Cons: Functions as more of a hydrating face wash than a deeply penetrating cleanser, which may not be the best fit for oily or acne-prone skin types Skip the 12-step beauty routine and complicated active ingredients. The Elizabeth Arden Eight Hour HydraPlay 2-in-1 Daily Cleanser is a refreshing return to effortless elegance. It's smart, effective and unpretentious — exactly what a cleanser should be. For less than $25, you'll be using a product that moonlights as both a gentle daily face wash and a skin-softening, one-minute mask. The texture alone, a dreamy whipped mousse, is enough to make washing your face feel like a small luxury. But this isn't just about indulgence; the results are there. At the heart of HydraPlay is a formula that reads like a skincare wish list: pink kaolin clay to purify without stripping, glycerin to replenish lost moisture and a ProRenewal Complex with pre- and post-biotics to support your skin's barrier like a good friend who texts you back. It's skincare that multitasks, quietly addressing everything from clogged pores to surface dryness, all while keeping your microbiome happy. The result? A complexion that feels smooth, balanced and — dare I say — glowy, without the tightness or irritation that so often follows a deep cleanse. It's one of my favorites, hands down. And if you need proof it's more than just pretty packaging, the formulation speaks for itself. After using, my skin feels healthier-looking, more moisturized and with less pores. Translation: you don't need a cleanser that'll cost you two Benjamins. Best Makeup Remover: Aveeno Positively Radiant Makeup Removing Wipes Amazon Pros: Gentle on the skin Actually removes all makeup Doesn't clog pores Cons: May be too drying for extremely dry or flaky skin types Aveeno's Positively Radiant Makeup Removing Wipes transform a simple cleansing step into a moment of skin-loving luxury, all without demanding a premium price. Priced well under $25, these wipes harness the power of soy extract to not only dissolve makeup but subtly brighten and even out my complexion whenever I use them on my face and eyelids. Their gentle, oil-free, sulfate-free and alcohol-free formula is a thoughtful nod to sensitive skin, delivering a soothing yet effective cleanse that feels anything but basic. Victoria Giardina They're even ophthalmologist-tested and safe for contact lens wearers, and effortlessly remove stubborn eye makeup without causing irritation or redness — a rare feat in the wipe world. Their non-comedogenic formula keeps my pores clear and skin breathable, and I always wake up with a fresh face rather than a breakout. Whether I'm rushing through my nighttime routine or in need of a oil-blotting-esque refresh, these wipes perform with an easy confidence that makes them an indispensable staple. This is a two-pack, which is still less than $25! Best Face Sunscreen: The Face Shop Hydro Sun Barrier Broad Spectrum SPF 45 Sunscreen Amazon Pros: Silky smooth, lightweight formulation Layers well underneath makeup with no white cast Contains niacinamide to help soothe the skin Cons: Isn't 100% fragrance-free, though not a dealbreaker Listen, I've tested a boatload of sunscreens (seriously, you should see my dresser drawer — and yes, I have a dresser drawer filled with SPFs). Throughout my many years of testing, I learned that not all sunscreens were created equal — and The Face Shop Hydro Sun Barrier Broad Spectrum SPF 45 Sunscreen is truly a standout. While I rated the La Roche-Posay Anthelios Clear Skin Sunscreen Broad Spectrum SPF 60 as the best face sunscreen I reviewed for most people, I've been resorting to this Korean beauty formula that's one of my favorite 2025 beauty launches. It's lightweight, doesn't leave a white cast and doubles as a silky smooth makeup primer. What's not to love? On its formulation, it's infused with niacinamide and calendula, allowing it to shield my skin from harmful UV rays but also brighten and soothe it, which visibly enhances my overall skin tone and texture. These ingredients work together to provide a subtle radiance, making the sunscreen a dual-purpose product that combines sun protection with serum-like benefits. This thoughtful formulation ensures that my face is in a state of perpetual nourishment, all while being protected throughout the day. Amazon Pros: Affordable price point Excellent value for the money, given its jar size Absorbs well and contains cocoa butter and vitamin E for long-lasting hydration Cons: Not 100% fragrance-free, so it may not be the best choice for extremely sensitive skin types It may be considered too thick for humid climates If there's one body cream that's earned its place as a holy grail for dry skin, it's the NIVEA Cocoa Butter Body Cream. This affordable gem delivers a level of nourishment that rivals high-end counterparts — without the inflated price tag. Rich but never clumpy, the cream melts into the skin with a silky ease, flooding my *very* dry elbows, knees and heels with 48 hours of moisture. The secret lies in NIVEA's signature Deep Moisture Serum, a tried-and-true blend that feels less like a skincare product and more like a rescue mission for parched skin. Victoria Giardina The luxurious infusion of cocoa butter is like no other; it's a decadent, vitamin-rich emollient that has long been a skincare staple for good reason. Combined with antioxidant-packed vitamin E, the formula hydrates and actively works to restore my skin's elasticity, luminosity and overall health. It's the one I turn to most because of how deeply nourishing it is. There's a subtle, comforting scent of warm cocoa that lingers without overwhelming, making each application feel like a small act of self-care. In short: this isn't just body cream: it's a ritual, wrapped in a jar. Key ingredients: Cocoa Butter, Vitamin E | Size: 16 ounces | Fragrance: Cocoa Amazon Pros: Contains hyaluronic acid to hydrate and nourish the skin Available in a generous roster of shades Ergonomic and practical applicator Cons: Not 100% full coverage, though not a dealbreaker Looking for a foundation that feels like luxury without the price tag? Enter the L'Oréal Paris True Match Nude Hyaluronic Tinted Serum — the beauty world's cheeky secret weapon. It's makeup and skincare all wrapped into one, dripping with 1% hyaluronic acid to deliver that fresh‑face glow while evening out your tone with sheer to medium coverage. Picture your skin in HD, but, you know, softer, smoother and plumper. I'm a bit skeptical of drugstore foundations, but this tinted formulation makes my skin feel naturally airbrushed while remaining lightweight and flattering. In one hand you've got luminous mineral pigments, and in the other, hydration that lasts. This tinted serum has an all‑day satin finish that's plumping, breathable and noncomedogenic. It glides on like water, blends like a dream (fingers give the most radiant payoff) and stays put long after your 9-to-5 (or full wedding day) without creasing or melting. While designer brands may charge triple for a tinted serum, this little wonder is less than $25. So yes, it truly is your true match. Best Concealer: NYX Professional Makeup Bare with Me Concealer Serum Amazon Pros: Affordable price point Glides onto the skin and feels like skincare, offering hydration to the skin Great for brightening and helping to correct dark circles Cons: Limited shade range May not be enough for those who need full coverage The NYX Professional Makeup Bare with Me Concealer Serum is a game-changing product that brings a fresh take on concealers. This lightweight, serum-like formula instantly gives a natural, radiant finish that comes with buildable coverage. Right off the bat, I noticed that it effortlessly blurs imperfections, dark circles and blemishes. It's also infused with skincare ingredients like aloe vera and cucumber extract to not only conceal but also hydrate and soothe my skin. That said, it's perfect for long wear. The formula is also noncomedogenic, which means it won't clog your pores, and it's suitable for all skin types, including my sensitive skin. For less than $15, it offers a skincare-like finish that I always gravitate toward. Victoria Giardina Versatile and creamy (without being goopy), the Bare with Me Concealer Serum sets itself apart from other drugstore options. It blends seamlessly into the skin, providing a smooth, skin-like finish that doesn't feel heavy or cakey. If you're looking for light coverage to even out your skin tone or need to build up to a medium coverage for more stubborn blemishes, this concealer offers you the flexibility to tailor it to your needs. The serum formula ensures that it doesn't settle into fine lines or creases, so it's especially apt for mature skin or anyone seeking a more youthful appearance. Shade range: 16 colors | Good for: Dark circles, blemishes Amazon Pros: Extremely gentle and soothing Lightweight and layerable Clean ingredients Cons: May feel too watery for some The Anua Heartleaf 77% Soothing Toner isn't just a toner — it's skincare therapy in a bottle. It's beloved for a reason, containing 77% heartleaf extract (yes, that's a lot), a botanical known in Korean herbal medicine for its anti-inflammatory, anti-redness and skin-purifying magic. When I use this product after my cleanser, I love how the lightweight, watery formula sinks in faster than a compliment on good skin, instantly calming irritation, bringing down visible redness and prepping my face like a blank canvas. Pro tip: soak a few cotton pads and press them onto inflamed areas for five minutes as a quick DIY calming mask. Where this toner really shines is in its quiet power. It's alcohol-free, fragrance-free and low-pH, meaning it respects your skin barrier instead of testing it. After cleansing, pat it gently into the skin with your hands; no need for cotton if you're aiming for full absorption. If your skin is dry or especially stressed, layer it. Yes, layer it. The '7-skin method' (applying toner in multiple light layers) makes this formula sing. It delivers bounce, hydration and visible clarity without any stickiness or shine. Key ingredient: Heartleaf Extract | Size: 8.45 ounces | Fragrance: None Best Razor: Billie Women's Shave Kit Amazon Pros: Produces a gentle, close chave The head is large enough to cut down shaving time Comes with a magnetic holder to place onto your shower wall Cons: The mechanism to replace the razor head could be more seamless and simple, though not a dealbreaker Shaving just got a serious upgrade, and it comes wrapped in a sleek matte handle with the name Billie. The Billie Women's Shave Kit is a thoughtfully engineered tool designed for real skin, real curves and real routines. At this point, it's basically the only one I use. With five ultra-sharp, nickel-free blades cushioned by aloe and charcoal shave soap, this razor glides like butter and leaves zero irritation in its wake. Whether I'm tackling tricky spots like knees and ankles or going for that all-over smoothness, Billie's pivoting head hugs every contour effortlessly. As someone prone to razor bumps, there aren't any nicks or bumps after using this tool, only a soft finish. Beyond the blade, Billie brings serious style and smarts to my shower. The magnetic holder is low-key genius (no more soggy razors laying around or questionable suction cups losing grip mid-rinse). The entire experience feels elevated: from the velvety handle (designed to never slip) to the easy snap-on cartridges that make blade-changing a breeze. It's minimal, it's functional and frankly, it looks like something I'm proud to display, not hide away in your caddy. And, perhaps the most refreshing part? Billie kicks the 'pink tax' to the curb. At less than $15 for the starter kit — which includes the razor, two refill cartridges, and the magnetic holder — it's high performance without the high markup. Refills are affordable, flexible via subscription and always cruelty free. This product is the new standard for shaving, and I recommend it to everyone. Best Makeup Primer: Neutrogena Healthy Skin Invisibly Radiant UV Primer SPF 30 Amazon Pros: Contains broad-spectrum SPF 30 that's recommended by dermatologists and protects against UVA and UVB rays Lightweight, blends well and cosmetically elegant Budget-friendly Cons: May be a bit too thin for some users, though isn't incredibly runny New from Neutrogena is its rockstar, less-than-$15 Healthy Skin Invisibly Radiant UV Primer SPF 30. It's a multi-functional product that combines skincare and makeup prep in one. This primer is impressively lightweight, provides a smooth, even base for foundation and offers the much-needed benefit of sun protection with broad-spectrum SPF 30. It's cosmetically elegant with an extraordinarily absorbable base. When I use it before my foundation, I instantly notice my skin looking more illuminated — simple radiance without that greasy feel or, worse: that unwanted white cast. It's the best makeup primer with SPF that I tested for its elegance and efficacy. In addition to SPF, this primer is infused with ingredients that promote healthier-looking skin. It contains a blend of antioxidants, including vitamins C and E, which help protect the skin from environmental stressors and free radical damage. These antioxidants not only work to protect your skin but also contribute to a more even, luminous complexion. So, I feel good whenever I use it. The primer is gentle on my sensitive skin, and I'd anticipate it working well on all skin types as it's not dryer nor greasy. It's also free from harsh chemicals or fragrances that could cause irritation. The inclusion of SPF 30 makes this primer an excellent option for daily use, as it provides essential sun protection while preparing your skin for makeup. It helps shield the skin from harmful UVA and UVB rays that contribute to premature aging and skin damage. Its smooth, radiant finish complements any makeup look, and I'm especially excited to continue using this Neutrogena primer during the warmer months. Size: 1 fl oz. | Base: Cream | Finish: Glowy | Best for: All Skin Types Best Eye Cream: Good Molecules Yerba Mate Wake Up Eye Gel Amazon Pros: Budget-friendly Instantly brightens, which is seriously impressive for a less-than-$10 product Feels silky smooth once applied Cons: Not much product in the tube, though not a dealbreaker If your under-eyes are crying out for a wake-up call, the Good Molecules Yerba Mate Wake Up Eye Gel is the kind of skincare SOS they've been waiting for. This cooling gel is powered by yerba mate extract, a natural source of antioxidants and caffeine that instantly perks up dullness and fatigue. The texture is light-as-air and absorbs in seconds, leaving no residue behind — just smoother, fresher-looking skin that feels as energized as it looks. From the first time I used this product, I was blown away. It's the product you reach for on those mornings when the snooze button won and you need to fake wide-awake in five minutes flat. What sets this brightening eye gel apart is its clean, targeted formula. It boasts caffeine to de-puff, peptides to firm and smooth and yerba mate to energize and protect — all working in harmony to revive the delicate eye area without overwhelming it. It layers beautifully under concealer, doesn't pill and won't irritate even the most sensitive skin. Plus, it's affordable enough to repurchase without flinching, which feels like a small luxury in a world where eye creams can cost more than a fancy dinner out. This isn't the kind of product that screams for attention; it quietly earns your loyalty with every early morning and late night. It's effortlessly effective, refreshingly straightforward and perfectly designed for real life. The silky texture is unbelievable, and it leaves an impressive glow that's worth screaming about (seriously). Best Blush: Versed Shade Swipe Blush Stick Versed Pros: Simple to apply with a brush or your fingers Best for travel Leaves your skin with a long-lasting flush of color Cons: Plastic cover sometimes becomes filled with product, though not a dealbreaker The Versed Shade Swipe Blush Stick is the blush BFF I never knew I needed. First off, the formula is a dream: creamy, lightweight and melts seamlessly into my skin, giving me that 'just pinched' flush without any staining or clown-face vibes. It's buildable, too. You can go from a whisper of rosy glow to a deep, camera-ready flush in a few swipes. It's truly so creamy, dreamy buildable and blendable, and that it breathes new life into my fair skin. However, its variety of shades complement any skin tone. In short: swipe, blend, blend and voilà — cheeks that look alive and effortlessly gorgeous. Now let's talk multitasking hustle. This chubby stick doubles as a lip tint or soft eyelid wash when you're going for that cute monochrome moment. Plus, it's clean (no fragrance or alcohol), full of skin-friendly emollients like caprylic triglyceride and coco-caprylate and priced less than $20. All in all, it's one my makeup bag needs at all time. Victoria Giardina Pros: Creamy finish 'The perfect nude pink lipstick' Cons: Packaging could be better, compared to some others tested For those who want to save money and have an everyday, pinky nude lipstick, run to L'Oreal Paris Glow Paradise Hydrating Balm-in-Lipstick with Pomegranate Extract (specifically, the shade '110 Pastel Exaltation'). Much to my delight, it measured up to some high-end lipsticks I've tried, its creaminess on-par with some $20 and $30 options in my makeup bag. The L'Oréal Paris Glow Paradise Hydrating Balm‑in‑Lipstick stands out as the ultimate nude lipstick thanks to its buttery balm-meets-pigment formula: infused with pomegranate extract, it delivers immediate hydration and a healthy, glassy sheen, yet still offers buildable color that flatters diverse skin tones. While the packaging could be more secure, the beauty lies in the formulation. It's worth every penny, and a good pick-me-up if you're seeking that nude-pink hybrid. How I tested An assortment of the beauty products I tested — all under $25. Victoria Giardina Ahead, here's the criteria for how I tested each beauty item under $25: Effectiveness: I evaluated how well each product delivered on its claims (including hydration, coverage and longevity). I evaluated how well each product delivered on its claims (including hydration, coverage and longevity). Ingredients: I reviewed the ingredient list for safety, quality and the presence of any potentially irritating or harmful substances. I reviewed the ingredient list for safety, quality and the presence of any potentially irritating or harmful substances. Application & Texture: I assessed how smoothly the product applied, absorbed or blended into my skin or hair. I assessed how smoothly the product applied, absorbed or blended into my skin or hair. Wear Time: I monitored how long the product lasted throughout the day under typical conditions, like heat, sweat and movement. I monitored how long the product lasted throughout the day under typical conditions, like heat, sweat and movement. Value for Price: I compared the overall performance and quantity of each product relative to its price, ensuring it offered good quality within the $25 budget. This article was written by Victoria Giardina, New York Post Commerce Journalist & Content Strategist, who has spent countless hours researching, testing hundreds of products and comparing the latest makeup, skincare, hair and beauty items and trends to determine what's truly worth your hard-earned cash. She evaluates formulas, textures, ingredients and more, in addition to consulting medical and industry experts. Some of Victoria's latest conquests include testing the best vitamin C serums on the market, and a rinse-and-repeat review of the best shampoos of 2025. Victoria, who received a beauty industry essentials certification from the Fashion Institute of Technology, has been creating shopping guides for the New York Post since 2021 and previously held positions at Insider Reviews and CNN Underscored.
Yahoo
an hour ago
- Yahoo
Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys
The ground shook for Sarepta Therapeutics, Inc. (NASDAQ:SRPT) last week as the U.S. Food and Drug Administration (FDA), alarmed by a third patient death tied to its gene therapy platform, pulled a rare move: requesting a voluntary halt to Elevidys shipments. The company's response? A resounding 'no,' igniting a major regulatory clash with severe implications for patients and investors alike. The upheaval began on Friday when the U.S. Food and Drug Administration (FDA) made a rare and impactful announcement: it had placed Sarepta's investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold. This decision stemmed from serious safety concerns, including three patient deaths potentially linked to these products, indicating that study participants faced or would be exposed to an unreasonable and significant risk of illness or injury. In light of these developments, the FDA also formally requested Sarepta to voluntarily halt all shipments of Elevidys, the company's approved gene therapy. However, in a move that set the stage for a major regulatory clash with severe implications for both patients and investors, Sarepta definitively refused this three fatalities, which prompted the FDA's strong action, have resulted from acute liver failure in individuals who had received either Elevidys or an investigational gene therapy utilizing the same AAVrh74 serotype, a viral vector used in gene delivery. Notably, one of these deaths occurred during a clinical trial for LGMD, conducted under an investigational new drug application. Adding to Sarepta's challenges, the FDA further revoked the platform technology designation for the company's AAVrh74 Platform Technology. This designation, typically granted to technologies with broad therapeutic promise that can streamline regulatory review, was rescinded because, given the new safety information, the preliminary evidence was deemed insufficient to demonstrate that the AAVrh74 Platform Technology could be incorporated into or utilized by multiple drugs without adverse effects on safety. Elevidys had received traditional approval in June 2024 for ambulatory Duchenne muscular dystrophy (DMD) patients aged four years and older with a confirmed DMD gene mutation. Previously, in June 2023, it secured accelerated, conditional approval for non-ambulatory DMD patients. However, continued approval for non-ambulatory patients is contingent upon verification of clinical benefit through confirmatory trials. With the emergence of this new safety data, the FDA notified Sarepta that Elevidys's indication should now be restricted solely to ambulatory patients. The FDA is continuing its investigation into the risk of acute liver failure, including severe outcomes such as hospitalization and death, associated with gene therapies employing Sarepta's AAVrh74 Platform Technology, and is prepared to take further regulatory actions as necessary. Despite the FDA's stance, Sarepta issued a statement on Friday affirming its decision to continue shipping Elevidys to the ambulatory patient population. The company asserted that its 'comprehensive scientific interpretation of the data... shows no new or changed safety signals in the ambulant patient population.' Sarepta also expressed its commitment to ongoing discussions and information sharing with the FDA to advance their 'shared purpose of protecting patient safety and informed access to care.' The company clarified that the most recent fatal event occurred in a Phase 1 clinical trial for an investigational gene therapy called SRP-9004, which is designed to treat a different condition, LGMD Type 2D. Sarepta emphasized that SRP-9004 is administered at a different dose and manufactured using a distinct process from Elevidys. Furthermore, the LGMD study participant who passed away was not treated with Elevidys, and dosing for the SRP-9004 trial had already concluded at the time of death. Sarepta reported this acute liver failure (ALF) event as a life-threatening case to the FDA on June 20 and subsequently notified the agency of the death on July 3. Looking ahead, Sarepta plans to submit the findings of an expert panel and a proposed protocol to the FDA. They will also discuss a proposal to collect additional data on a modified treatment regimen in a new cohort (Cohort 8) of the ENDEAVOR study (Study SRP-9001-103). This is intended as a pathway to re-establish dosing for non-ambulant patients in the future. Price Action: As of Monday's premarket session, Sarepta's stock was down 6.79% at $13.12, reflecting the ongoing concerns and market reaction to these significant developments. Read Next:Photo via Shutterstock Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? SAREPTA THERAPEUTICS (SRPT): Free Stock Analysis Report This article Sarepta's Shocking Stand: Company Rejects FDA Request To Pull Gene Therapy Elevidys originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved.
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NKGen Receives FDA Expanded Access Protocol Authorization for Landmark Treatment of Several Neurodegenerative Diseases
Troculeucel, a cryopreserved, autologous enhanced natural killer cell therapy, has demonstrated preliminary clinical benefit without any drug-related adverse events in two Phase I clinical trials in Alzheimer's Disease. Company receives expanded access protocol authorization from the U.S. Food and Drug Administration (FDA) for troculeucel granted to treat patients with known diagnoses of multiple neurodegenerative diseases. IND approval allows for up to 20 patients to be enrolled; first patient enrollment is anticipated in Q3 2025. SANTA ANA, Calif., July 21, 2025 (GLOBE NEWSWIRE) -- NKGen Biotech, Inc. (OTC: NKGN) ('NKGen' or the 'Company'), a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic natural killer ('NK') cell therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access Program (EAP) authorization for its IND for an open-label, non-randomized, multi-center intermediate size expanded access protocol for use of troculeucel for neurodegenerative diseases. This includes its use for the treatment of several neurodegenerative diseases, many of which currently have no effective therapy. While NKGen's ongoing double-blind randomized Phase 2a trial is focused on moderate-stage Alzheimer's disease (NCT06189963), this EAP IND marks the company's exploration into the treatment of other less common neurodegenerative diseases. In addition to earlier stage Alzheimer's Disease (AD), this IND includes the treatment of Parkinson's Disease (PD), Amyotrophic Lateral Sclerosis (ALS), Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Frontotemporal Dementia (FTD), Corticobasal degeneration (CBD), Multiple Sclerosis (MS) and Lewy Body Dementia (LBD). This IND approval will allow NKGen to expand and explore the use of troculeucel in up to 20 patients. 'There is a common element of autoimmune neuroinflammation in all of these neurodegenerative diseases due to autoreactive T cells, many in response to either an amyloid, alpha-synuclein, or tau protein deposition,' said Paul Y. Song, MD, Chairman and Chief Executive Officer of NKGen Biotech. 'As we have demonstrated in two Phase I trials in Alzheimer's Disease, troculeucel, given via a simple IV, appears to cross the blood brain barrier to reduce neuroinflammatory and protein biomarkers in CSF. We believe there is ample scientific and clinical rationale to offer this to patients with other neurodegenerative diseases for which there is no effective therapy and little hope. We will begin enrolling patients as soon as possible, but the speed of enrollment will depend on funding.' About NKGen Biotech NKGen is a clinical-stage biotechnology company focused on the development and commercialization of innovative autologous and allogeneic NK cell therapeutics. NKGen is headquartered in Santa Ana, California, USA. For more information, please visit About Troculeucel Troculeucel is a novel cell-based, patient specific, ex vivo expanded autologous NK cell immunotherapeutic drug candidate. NKGen is developing troculeucel for the treatment of neurodegenerative disorders and a broad range of cancers. Troculeucel is the International Nonproprietary Name ('INN') for SNK01 assigned by the World Health Organization ('WHO'). The WHO INN approval of troculeucel establishes a universally recognized nonproprietary drug name for SNK01 and marks a significant step on NKGen's journey toward bringing this therapy to market. Forward-Looking Statements Statements contained in this press release may contain 'forward-looking statements' within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of words such as 'anticipate', 'believe', 'could', 'continue', 'expect', 'estimate', 'may', 'plan', 'outlook', 'future' and 'project' and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company's control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company's plans and expected timing for developing troculeucel and SNK02, including the expected timing of completing and announcing further results from its ongoing clinical studies; and the Company's expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the Company's ability to execute its plans and strategies; risks related to performing clinical studies; the risk that initial and interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; the risk that the abstract will not be published as planned including delays in timing, format, or accessibility; and NKGen's ability to raise additional funding to complete the development of its product candidates. These and other risks and uncertainties are described more fully under the caption 'Risk Factors' and elsewhere in the Company's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission's website at and on the Company's website under the subheading 'Investors—Financial and Filings'. Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Internal Contact: Denise Chua, MBA, CLS, MLS (ASCP)SVP, Corporate Affairs949-396-6830dchua@ External Contact: Kevin GardnerManaging DirectorLifeSci Advisors, LLCkgardner@
