Sunvozertinib Wins Approval for EGFR-Mutated NSCLC
The agency also approved Oncomine Dx Express Test (Life Technologies Corporation) as a companion diagnostic to detect the mutations.
The oral EGFR inhibitor is the first small molecule approved in the US for the indication; it was previously approved in China.
The intravenous bispecific antibody amivantamab-vmjw (Rybrevant, Johnson & Johnson) also carries a second-line indication for EGFR exon 20 insertion mutated advanced/metastatic NSCLC, as well as a first-line indication with carboplatin and pemetrexed.
Dizal is going for a first-line indication, too. The company recently announced completion of enrolment in a phase 3 trial pitting sunvozertinib against platinum-based chemotherapy for the upfront treatment of EGFR exon 20 insertion mutated NSCLC.
The new second-line approval was based on WU-KONG1B, a multinational dose finding trial. All subjects had previous platinum-based chemotherapy and 43.4% had also received immunotherapy; 13.3% had been on amivantamab.
Among 85 patients on 200 mg sunvozertinib daily, the overall response rate was 46% and the duration of response was 11.1 months.
Labelling warns of the possibility of interstitial lung disease/pneumonitis, gastrointestinal adverse reactions, dermatologic issues, ocular toxicity, and embryo-fetal toxicity. Diarrhea, skin rash, and creatine phosphokinase increase were the most common drug-related treatment emergent adverse events in the trial, with most events being grade 1 or 2.
The recommended dose is 200 mg orally once daily with food until disease progression or unacceptable toxicity.
M. Alexander Otto is a physician assistant with a master's degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who worked for several major news outlets before joining Medscape. Alex is also an MIT Knight Science Journalism fellow. Email: aotto@mdedge.com
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
32 minutes ago
- Yahoo
High-Potency OTC NMN Supplement from Wonderfeel Launches Amid Surging Demand for Clean NAD+ Support Solutions
Wonderfeel's 2025 Youngr™ update features a 900mg stabilized NMN dose with antioxidant co-factors, formulated to align with consumer interest in bioavailable, non-synthetic NAD+ wellness support. New York, July 03, 2025 (GLOBE NEWSWIRE) -- Wonderfeel Releases 2025 Youngr™ NMN Supplement to Meet Rising NAD+ Wellness Interest Section 1 – Introduction In 2025, interest in age-related health optimization continues to rise, with consumers increasingly seeking solutions that align with non-clinical, cellular wellness approaches. The search volume for 'NAD supplements,' 'NMN safety,' and 'anti-aging support without drugs' reflects a growing demand for transparent alternatives rooted in longevity science. The public is demonstrating increased awareness of cellular health concepts such as NAD+ (nicotinamide adenine dinucleotide), a naturally occurring coenzyme associated with various metabolic functions that decline with age. Conversations across digital platforms and bioscience publications are now spotlighting ingredients like NMN (nicotinamide mononucleotide) as part of a broader trend toward proactive aging support. This reflects a cultural shift away from reactive pharmaceutical treatments and toward non-prescription solutions built around energy metabolism, mitochondrial integrity, and daily resilience. While NMN is not FDA-approved for treating any conditions, its scientific exploration in the context of human aging has sparked wide public curiosity. Consumers are now asking more nuanced questions about bioavailability, delivery mechanisms, and purity in NAD+ precursor formulas. This has placed pressure on supplement companies to be more transparent about ingredient sourcing, clinical validation, and manufacturing standards. In this evolving wellness space, brands are responding with elevated disclosure around formulation design and scientific development. The search for a sustainable, well-researched NAD support product—without exaggerated claims or invasive interventions—is driving current public interest. This release situates Wonderfeel's latest updates within that broader search for credible information about non-synthetic support for cellular vitality. To access additional information about the formulation and ingredient sources, visit the official platform. What Makes Youngr™ a High-Potency NMN Formula? Section 2 – Product/Company Update Wonderfeel's 2025 update to its patented NMN supplement, Youngr™, reflects the company's continued focus on formulation stability, ingredient transparency, and non-synthetic innovation in the NAD+ wellness category. The latest version delivers 900 mg of NMN in two capsules, incorporating refinements intended to support ingredient integrity and bioavailability. The Youngr™ formulation includes a proprietary combination of stabilized NMN reinforced by additional compounds selected for their roles in wellness science discussions. These include ergothioneine, resveratrol, hydroxytyrosol, and vitamin D3—each examined in scientific literature for their potential involvement in cellular function and oxidative balance. Their inclusion reflects Wonderfeel's interest in nutrient synergy and formulation logic, aligning with ongoing public interest in multi-ingredient approaches to support healthy aging. According to Wonderfeel, the product is developed to help protect NMN from oxidative degradation and enable efficient delivery, addressing common concerns regarding NAD+ precursor stability. The formulation avoids synthetic preservatives and animal-derived ingredients, and is manufactured in cGMP-certified facilities in the United States using non-GMO, vegan-friendly capsules. This update underscores the company's broader emphasis on consumer education, scientific clarity, and ingredient traceability. While Youngr™ is not intended as a treatment or diagnostic product, Wonderfeel positions it within the non-clinical supplement landscape as part of a larger conversation around cellular wellness and longevity research. Section 3 – Consumer Trend Overview Over the past 18 months, public interest in NMN supplements and NAD+ support has grown significantly, as reflected in rising search volume for terms such as 'how to raise NAD levels' and 'natural anti-aging solutions.' This shift marks a broader trend in which consumers increasingly seek non-pharmaceutical wellness strategies rooted in cellular health science. Conversations across online forums, lifestyle media, and scientific publications have highlighted NAD+ metabolism as a point of focus for individuals exploring healthy aging. Interest has evolved from general awareness of longevity supplements to more detailed inquiries about formulation quality, ingredient interactions, and absorption mechanisms. As consumers become more educated about NAD+ pathways, their expectations for product transparency have also increased. Many now evaluate supplements not only by dosage, but by the presence of complementary ingredients like resveratrol or ergothioneine. These patterns indicate a preference for holistic formulations designed with oxidative support and ingredient synergy in mind. Wonderfeel's presence in these discussions reflects a response to the growing demand for clean-label, non-synthetic options. The company's focus on clinical authorship, cGMP manufacturing, and open-access ingredient rationale aligns with consumer behavior that prioritizes research-backed information over exaggerated claims. Further background on the product's development and ingredient disclosures is available through the company's official information portal. Inside the Clean-Label Design: NMN, Resveratrol, and Antioxidant Synergy Section 4 – Ingredient or Technology Spotlight The 2025 Youngr™ formula by Wonderfeel includes a curated blend of compounds that have been the subject of interest within cellular wellness and longevity research communities. At the core is 900 mg of stabilized NMN (nicotinamide mononucleotide), a compound studied for its relationship to NAD+ production. Wonderfeel reports that the NMN used in the formulation is tested for 99% purity and protected against oxidative degradation, a common concern in NAD+ precursor stability. Ergothioneine (ERGO), a naturally occurring amino acid antioxidant found primarily in mushrooms, is included for its cytoprotective properties as discussed in emerging wellness literature. Resveratrol, a polyphenol found in grapes, is often noted for its connection to sirtuin activation—proteins that play a role in cellular regulation. Vitamin D3 is incorporated as a widely studied nutrient essential to immune and cellular health, while hydroxytyrosol, derived from olives, has gained attention as a plant-based antioxidant. Although none of these ingredients are approved as therapeutic agents, their combination in the Youngr™ formulation reflects Wonderfeel's approach to synergistic ingredient design within a non-clinical wellness context. Section 5 – User Journey Narrative or Market Reception As cellular wellness gains broader visibility, consumers increasingly approach the supplement space with informed research habits—beginning with keyword searches and progressing to ingredient-specific comparisons. NMN has emerged as a recurring topic of interest, particularly among those exploring non-invasive wellness routines centered on energy, focus, and resilience. Wonderfeel's Youngr™ formulation has entered these discussions through its positioning around scientific clarity and formulation strategy. Online engagement frequently centers on ingredient synergy, capsule stability, and delivery methods—areas in which consumers express a desire for practical, transparent solutions rather than exaggerated performance claims. Market sentiment continues to show interest in supplements that emphasize clean sourcing and non-pharmaceutical design. Products like Youngr™, which incorporate multiple co-factors and align with peer-reviewed science, tend to attract audiences looking for educational content over promotional messaging. While regulatory boundaries around NAD+ precursors remain under review, public discourse has shifted toward evaluating supplement brands on formulation logic, evidence of quality standards, and open communication practices. Meeting Consumer Expectations: Non-Synthetic NAD+ Support in 2025 Section 6 – Availability and Transparency Statement Wonderfeel's Youngr™ NMN formulation is available through the company's official platform, where additional information on ingredient sourcing, formulation rationale, and manufacturing standards is publicly accessible. The supplement is manufactured in the United States in facilities that follow Current Good Manufacturing Practices (cGMP), with each batch independently tested to confirm purity, stability, and composition. Youngr™ is designed for individuals interested in non-clinical NAD+ support options and reflects Wonderfeel's broader commitment to transparency in the wellness space. While not a diagnostic or therapeutic product, the company positions its formulation within the context of informational consumer interest in cellular health strategies. Wonderfeel encourages individuals to consult with qualified healthcare providers when considering any supplement or wellness product. Content shared through the company's official site is intended for informational purposes only and is not a substitute for professional medical guidance. Additional insights into the development of this NAD+ support product are available through the company's dedicated resource page. Section 7 – Final Observations & Industry Context The NAD+ support category continues to grow as scientific research and public curiosity converge around cellular function, aging, and metabolic resilience. As consumers become more selective and informed, the wellness industry has responded with a greater focus on formulation disclosure, ingredient sourcing, and clean-label development. In 2025, regulatory conversations surrounding NMN and other NAD+ precursors remain ongoing, reinforcing the importance of clear boundaries between lifestyle supplements and medical interventions. Companies that emphasize non-clinical positioning, published references, and ingredient transparency are increasingly viewed as credible contributors within the category. Wonderfeel's approach—combining stabilized NMN with complementary compounds like ergothioneine, resveratrol, and hydroxytyrosol—reflects a broader movement toward multifunctional, synergy-based product design. As interest in cellular wellness continues to rise, the company's emphasis on evidence-informed development and public accessibility positions it to remain a relevant participant in the evolving NAD+ landscape. Section 8 – Public Commentary Theme Summary Public discussions around Wonderfeel's Youngr™ formulation often center on ingredient composition, purity, and rationale. Across wellness communities and digital forums, the 900 mg stabilized NMN dose has prompted inquiries into daily tolerability and delivery mechanisms. The presence of less common ingredients such as ergothioneine and hydroxytyrosol has also attracted attention from consumers interested in antioxidant research and oxidative stress support. Resveratrol, widely discussed in the context of sirtuin activation, is frequently mentioned as part of comparative discussions involving NAD+ formulations. While regulatory clarity on NAD+ precursors continues to evolve, online commentary reflects a growing consumer base that values formulation detail, clean-label design, and scientific transparency. Overall, consumer discourse surrounding Youngr™ is shaped by an interest in how ingredients work together rather than by marketing narratives. This reflects a wider shift toward informed supplement use, with emphasis on non-synthetic formulation, ingredient integrity, and publicly accessible science. About the Company Wonderfeel develops wellness formulations designed to align with evolving standards in scientific transparency and ingredient integrity. Founded with a mission to modernize non-clinical health support through evidence-informed innovation, the company focuses on ingredient purity, manufacturing consistency, and open access to formulation rationale. The Wonderfeel team includes biomedical researchers and industry contributors committed to advancing wellness products that reflect both emerging science and public interest. All Wonderfeel supplements are manufactured in the United States at cGMP-certified facilities using vegan-friendly, non-GMO ingredients. Wonderfeel does not make medical claims and maintains a clear distinction between lifestyle support products and regulated therapeutics. The company's communications are intended to inform consumers, support research-driven decision making, and foster transparency within the supplement industry. Contact: Wonderfeel Email: info@ Website: CONTACT: Email: info@ Website:
Yahoo
41 minutes ago
- Yahoo
So, Your Dog Definitely Knows When You're Stressed–Here's How
So, Your Dog Definitely Knows When You're Stressed–Here's How originally appeared on PetHelpful. Understanding dog behavior will never not be totally interesting. From having their own love languages to specific barks having unique meanings, dogs are truly complex and amazing creatures with their own rich inner worlds. As it turns out, the bond between dog and owner goes even deeper than you might have ever imagined, so much so that a dog can even detect when their person is stressed out. 🐾 SIGN UP to get "pawsitivity" delivered right to your inbox with inspiring & entertaining stories about our furry & feathered friends along with expert advice from veterinarians and pet trainers 🐾 In an interview with American Kennel Club (AKC), Dr. Zoe Parr-Cortes, veterinarian and PhD graduate from the University of Bristol, explained how dogs can pick up on their owner's mental state through various cues."As one of our closest companions, dogs have co-evolved alongside humans for thousands of years. Because of this, both humans and dogs have learned to recognize cues in each other that signal how the other is feeling. Several studies have demonstrated that dogs respond to the sights and sounds of various human emotions, including crying, vocal tones, and facial expressions," Dr. Parr-Cortes explained to AKC. In addition, dogs also can sense stress through scent. According to research published in PLOS One, dogs can actually detect stress from sweat and breath samples through their sense of smell. In this study, baseline sweat and breath samples were taken from human participants. After that, the researchers administered math tests with the goal of causing the participants stress (side note: that would absolutely work to make me panic) and then collected a second round of samples. When the researchers presented the dogs with the samples, the canine participants could distinguish the baseline from the stress samples with over 90% accuracy thanks to a shift in the breath and sweat samples' volatile organic compounds, which is detectable to dogs' noses. More recent research conducted by Dr. Parr-Cortes and other members of the Animal Welfare and Behaviour Group at Bristol Vet School sought to understand exactly what it is the dogs are smelling that allow them to detect stress in those samples. While it was unclear whether the dogs in this particular study were responding to the humans' cortisol, adrenaline or other stress markers, this study opened up more avenues to further test what the dogs are sensing that makes them detect stress. Either way, pretty interesting stuff!So, Your Dog Definitely Knows When You're Stressed–Here's How first appeared on PetHelpful on Jun 23, 2025 This story was originally reported by PetHelpful on Jun 23, 2025, where it first appeared.
Wall Street Journal
42 minutes ago
- Wall Street Journal
Orphan Drugs Are Neglected No More
A bill as large as the GOP reconciliation budget takes time to pore through, and we can now report a hidden gem: It fixes the Inflation Reduction Act's disincentive to develop treatments for rare diseases. The IRA was a woeful bill in countless ways, but the worst is its Medicare drug price controls. The early damage has been less investment in so-called orphan drugs for rare diseases. Because the pool of patients is small, manufacturers have to set higher prices to recoup their investment. This makes them an attractive target for Medicare bureaucrats. The IRA price controls exempted orphan drugs, but only if they are approved for a single indication. They lose their exemption if they are used to treat more than one rare disease, though many diseases share an underlying pathology such as a gene mutation. Of the 280 orphan drugs approved between 2003 and 2022, 63 were approved later for another indication. The law has discouraged companies from studying orphan drugs for multiple rare diseases. Some face a Hobson's choice. If an experimental medicine works for two rare diseases, companies might have to jettison one use lest their drug become subject to price controls and return on its investment collapse.
