Latest news with #UnitedStatesFoodandDrugAdministration
Yahoo
20 hours ago
- Business
- Yahoo
Blue Bell Just Announced a Big Change to Its Ice Cream
Your favorite pint could be affected. On January 15, the United States Food and Drug Administration (FDA) announced a ban on Red No. 3, a move that affects a large number of items across the food and beverage industry. The artificial additive is used in a number of popular grocery items, including candy and desserts, to achieve a bright red color. To be compliant with new federal guidelines, companies must phase it out completely by 2027. Ahead of the deadline, many industry giants have already announced plans to remove not just Red No. 3, but all artificial colors from their products. In June, Kraft Heinz announced that it will not launch any new products containing Federal Food, Drug, and Cosmetic (FD&C) colors in the U.S. Additionally, it will remove all remaining artificial dyes by the 2027 deadline. Hershey and Nestlé have also made recent statements about how their products will be modified to comply with new guidelines. Now, Texas-based creamery Blue Bell is the latest to share its plans for the upcoming transition. Blue Bell Announces Plans To Remove Artificial Colors From Its Products On July 14, the International Dairy Foods Association (IDFA) announced that dozens of U.S. ice cream companies have committed to removing artificial colors in their products. In a recent statement on X, Blue Bell said that it is proud to be part of the IDFA commitment to eliminate certified artificial colors from its products, a list that includes Red No. 3, Red No. 40, Green No. 3, Blues No. 1 and 2, and Yellows No. 5 and 6. The post also contains an image with a list of Blue Bell flavors that are already free from artificial colors, such as Bride's Cake, Java Jolt, and Homemade in the Shade, which recently returned to stores after more than a decade-long hiatus. Many of the ice cream flavors that already meet dye-free guidelines are vanilla or chocolate-based. But what about flavors such as Christmas Cookies and Cotton Candy, which use artificial color blends to achieve their vibrant hue? Blue Bell told Allrecipes that customers can expect the revamped ice cream to maintain the flavor fans love. "The taste, texture, and fun of our ice cream will remain the same—the ingredient list is getting a refresh," the brand wrote in a recent email. At this time, it's not clear which Blue Bell flavors will be introducing a new ingredient label this year, but the brand advises fans to stay up-to-date by following its social media accounts for information on new and returning flavors. Read the original article on ALLRECIPES Solve the daily Crossword
The Star
2 days ago
- Health
- The Star
Prostate cancer no longer a death sentence with this superior treatment option
Prostate cancer has long posed a significant health challenge for men. It was first identified in 1853 by Dr John Adams in London Hospital (now The Royal London Hospital) following histological post-mortem examination of the prostate gland. At that time, prostate cancer was considered a very rare disease but it is currently the sixth most common cancer in Malaysia and fourth most common cancer worldwide. The first surgical attempt at treating the cancer was carried out by Theodor Billroth in 1867 via partial prostatectomy, a surgical procedure where a portion of the prostate gland is removed. However, it was only 37 years later in 1904 when Dr Hugh Hampton Young performed the first perineal radical prostatectomy which is still practiced today though with modification and improvement in technique. Medicine is continuously evolving and when radioactive radium was discovered in 1898, it paved the way for the first brachytherapy procedure in 1909. The emitted radiation from radium was used to destroy the diseased prostate tissue. Since the beginning of 20th century, increasingly more men were diagnosed with prostate cancer, with the majority having metastatic disease at presentation. Fortunately in 1941, future Nobel Laureates, Drs Charles Huggins and Clarence V. Hodges published the landmark paper on the effect of castration, of oestrogen and androgen injection on serum phosphatases in metastatic carcinoma of the prostate. Their work accelerated studies on anti-androgen therapies which are still in use today. The prostate-specific antigen (PSA) test, discovered in 1980, revolutionised the detection and monitoring of prostate cancer. Over the past two decades, outlook for metastatic prostate cancer has evolved significantly with the introduction of various treatments such as denosumab, zolendronic acid, abiraterone, enzalutamide, olaparib and most recently the radionuclide-based PSMA (prostate-specific membrane antigen) therapy. Roots of PSMA PSMA was first identified by Murphy and Horoszewicz's team. They developed the capromab antibody which targeted the intracellular epitope of PSMA in 1987 and became the foundation of the first United States Food and Drug Administration (FDA)-approved molecular imaging agent for prostate cancer (ProstaScint) in 1996. Heston and Fair's group managed to clone the PSMA gene in 1993 and that led to a flurry of research up to the development of PSMA-based ligands for PET-CT imaging between 2011 and 2012. Since then, there has been many studies demonstrating the sensitivity and accuracy of PSMA PET-CT notably the ProPSMA trial. This multicentre phase 3 clinical trial demonstrated a 27% absolute improvement in diagnostic accuracy of PSMA PET-CT compared to conventional imaging of CT and bone scans. PSMA PET-CT imaging has been in Malaysia for many years but cost and availability of the services have always been an issue. It is expensive to set up and maintain the radiotracer generator and unless there is sufficient patient load and acceptable pricing, most hospitals do not offer PSMA services. Nonetheless, with the FDA-approval of Lutetium-177 PSMA Therapy ( Lu-PSMA) for metastatic castrate-resistant prostate cancer in 2022, there has been growing interest in PSMA PET-CT. Prostate cancers patients tend to present late as they are usually asymptomatic and most prostate cancers are found incidentally during blood test with elevated PSA levels. No man with a prostate gland is spared, and even former US President Joe Biden and the creator of Dilbert comic, Scott Adams, publicly revealed in May 2025 that they have metastatic prostate cancer. The 3D Ga68-PET images show the sites of the metastatic prostate cancer before and after treatment. There is significant reduction in the number of lesions and the PSA levels after three cycles of Lu-PSMA therapy. — Dr ALEX KHOO CHEEN HOE Differing treatment modalities Treatment for prostate cancer is very dependent on the stage of the disease. It is therefore very crucial for doctors to stage the disease accurately. The treatment for a patient with stage 1 prostate cancer is very different from a patient with stage 4 disease. PSMA PET-CT has been shown as aforementioned to accurately stage the cancer. For early stages and depending on the cancer-risks, treatment options include active surveillance, radical prostatectomy, brachytherapy, radical radiotherapy, long-term anti-androgen therapy (ADT) and various combinations. Fortunately for patients who develop metastatic disease, there are still treatment options available for those who are hormone naïve (ADT and novel therapies such as apalutamide, darolutamide, enzalutamide) or for those who developed castration-resistant disease (docetaxel, cabazitaxel, PARP inhibitors, Lu-PSMA therapy). In the past, having metastatic castrate-resistant prostate cancer was like a death sentence with clinician not having much treatment to offer. However, the 2015 introduction of Lu-PSMA therapy in the prostate cancer treatment armament has provided the much needed reprieve. Patient suitability Before doctors embark on treating metastatic castrate-resistant prostate cancer patients with Lu-PSMA therapy, PSMA PET-CT has to be done to determine if the patient is suitable for the treatment. If the cancerous lesions are not seen to demonstrate PSMA radiotracers on PET, then the patients are not suitable candidates for Lu-PSMA therapy. If the patient is suitable for treatment, the radioactive used – either gallium-68 (Ga-68) or fluorine-18 (18F) – in PSMA PET-CT of diagnostic value only is exchanged for a different radioactive (Lutetium-177) which has a therapeutic effect. Some clinicians would advocate doing both 18F-FDG (fludeoxyglucose) and PSMA-base ligand PET-CT upfront as baseline for better treatment selection but cost is usually an issue. Lu-PSMA therapy is a targeted therapy where intravenously administered radioactive (Lu-177) is is guided by the PSMA ligand to prostate cancer cells, which overexpress PSMA on their surfaces. The PSMA expression is 100-1,000 times higher in cancerous cells compared to normal tissue. This differs from conventional treatment (chemotherapy and radiotherapy) where the killing effect affects both normal and cancerous cells. With the highly selective target and short radiation range (1.5 to 3mm) in the body, the side effects from the radioactive treatment are relatively lower. This precision approach exemplifies the concept of 'theranostics,' where radioactive treatment can be imaged simultaneously, something unique to nuclear medicine. Following treatment with Lu-PSMA therapy, doctors are able to determine if the administered radioactive has been distributed to the targeted sites. Based on the post-therapy imaging, the doctors are also able to determine the next step in treatment. Prostate cancer continues to be a significant health concern, but early detection and the availability of advanced therapies offer hope. Men are encouraged to take proactive steps in maintaining prostate health, recognising that not all prostate issues stem from benign prostatic hyperplasia. With continuous advancements, particularly in PSMA-based theranostics, the outlook for patients with prostate cancer continues to improve. Lu-PSMA therapy stands at the forefront of this evolution, representing a critical step toward more effective and personalised cancer care. Dr Alex Khoo Cheen Hoe is a consultant nuclear medicine physician. For more information, email starhealth@ The information provided is for educational and communication purposes only, and should not be considered as medical advice. The Star does not give any warranty on accuracy, completeness, functionality, usefulness or other assurances as to the content appearing in this article. The Star disclaims all responsibility for any losses, damage to property or personal injury suffered directly or indirectly from reliance on such information.
Business Standard
24-07-2025
- Business
- Business Standard
Zydus receives USFDA tentative approval for Ibrutinib tablets
Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg (USRLD: Imbruvica tablets, 140 mg, 280 mg and 420 mg). Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion, and Waldenstrom's macroglobulinemia (WM). Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Ibrutinib tablets had annual sales of USD 2148.9 mn in the United States (IQVIA MAT May 2025). The group now has 420 approvals and has so far filed 484 ANDAs since the commencement of the filing process in FY 2003-04.
Business Standard
24-07-2025
- Business
- Business Standard
Zydus Lifesciences gets USFDA Nod for Ibrutinib tablets
Zydus Lifesciences informed that it has received tentative approval from the United States Food and Drug Administration (USFDA) for Ibrutinib tablets 140 mg, 280 mg, and 420 mg. Ibrutinib is a kinase inhibitor indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) with a 17p deletion, and Waldenstr's macroglobulinemia (WM). Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. The tablets had annual sales of $2,148.9 million in the United States (IQVIA MAT May 2025). The group now holds 420 approvals and has filed a total of 484 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The companys consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. Shares of Zydus Lifesciences rose 0.78% to currently trade at Rs 969.15 on the BSE.
Time of India
16-07-2025
- Business
- Time of India
Zydus Lifesciences shares in focus after USFDA nod for Celecoxib capsules
Zydus Lifesciences shares will be in focus after the company received final approval from the United States Food and Drug Administration ( USFDA ) for its Celecoxib capsules , a medication used for pain management. The approval covers Celecoxib capsules in strengths of 50 mg, 100 mg, 200 mg, and 400 mg, the company said in a regulatory filing on Tuesday. The drug will be manufactured at Zydus Lifesciences' facility in Ahmedabad. Celecoxib, sold under the brand name Celebrex, is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation caused by conditions such as arthritis, ankylosing spondylitis, menstrual pain, and juvenile rheumatoid arthritis in children aged two years and above. According to IQVIA data, Celecoxib capsules recorded sales of $122.6 million in the US for the 12 months ending May 2025. With this approval, Zydus now has 428 ANDA approvals and has filed a total of 492 since it began the process in FY2003-04. Live Events In June, the USFDA issued two observations following an inspection conducted between June 9 and 18 at the company's oncology injectable manufacturing facility at SEZ 1 near Matoda, Ahmedabad. Zydus Lifesciences shares target price According to Trendlyne, the average target price for Zydus Lifesciences shares stands at Rs 967, indicating a potential downside of 1% from current levels. Of the 30 analysts tracking the stock, most have maintained a 'Hold' rating. Zydus Lifesciences shares performance Zydus Lifesciences shares are down 19% over the past year but have gained 63% over the last two years. The company's current market capitalisation is Rs 97,317 crore. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)
