A dozen former FDA commissioners blast Prasad's proposed vaccine policy changes
fiercehealthcare - Drastic overhauls of U.S. vaccine regulations proposed by top FDA official Vinay Prasad, M.D., have drawn harsh pushback from 12 former commissioners of the agency.
AI Summary: A dozen former FDA commissioners have fiercely criticized the proposed overhaul of U.S. vaccine regulations spearheaded by FDA official Vinay Prasad, warning it could undermine decades‐old safety standards and erode public trust in immunization.
FDA approves all ages gene therapy for spinal condition
Ella Jeffries / beckershospitalreview - The FDA approved Novartis’ Itvisma (onasemnogene abeparvovec-brve), the company’s first and only gene replacement therapy for spinal muscular atrophy in children 2 and older, as well as for teens and adults. The therapy is designed to address the genetic …
AI Summary: The FDA has given the green light to Novartis’ gene replacement therapy Itvisma for the treatment of spinal muscular atrophy, a development that extends its use to patients of all ages. The approval, which responds to long‐standing concerns over safety and patient eligibility, marks a significant milestone in SMA care.
Novo submits high-dose Wegovy for FDA approval using voucher
Max Bayer / endpoints - Novo Nordisk submitted a higher dose of its obesity drug Wegovy for FDA approval and is using a recently-won voucher to expedite the review. The company said Wednesday that it submitted ...
AI Summary: Novo Nordisk has formally submitted its application to the FDA to approve a higher-dose formulation of its flagship obesity drug, Wegovy. Leveraging a recently secured priority voucher, the filing is set to potentially expand treatment options for weight management as the review process begins.
FDA Approves Pembrolizumab + Enfortumab Vedotin-ejfv for Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
oncodaily - What Does FDA Approval Mean? The U.S. Food and Drug Administration (FDA) evaluates new cancer therapies to determine whether they are safe and effective for clinical use. Approval is based […]
AI Summary: The U.S. Food and Drug Administration has approved a combination of pembrolizumab (Keytruda) and enfortumab vedotin (Padcev) for patients with muscle‐invasive bladder cancer who cannot tolerate cisplatin. Both agents—which have individually transformed treatment paradigms—are now linked in a perioperative setting that could alter outcomes for this aggressive cancer.
FDA Approves Ziftomenib for Relapsed or Refractory Acute Myeloid Leukaemia with a NPM1 Mutation
esmo - Evidence for efficacy is based on the results from the KO-MEN-001 study
AI Summary: The FDA has granted full approval for ziftomenib—a novel agent aimed at treating relapsed or refractory acute myeloid leukemia, especially in patients with NPM1 mutations. Backed by the KO‐MEN‐001 trial data, this decision marks a significant step forward for a patient group in dire need of new therapeutic options.
F.D.A. Will Remove Black Box Warnings From Hormone Treatments for Menopause
Roni Caryn Rabin / nytimes - The benefits of hormone replacement have been underappreciated, Dr. Marty Makary, the agency’s commissioner, said on Monday. Critics described evidence for the change as insufficient.
AI Summary: In a bold policy pivot, the FDA will lift long‑standing black box warnings on hormone treatments for menopause. The decision – made without an official advisory committee’s input – updates labeling to better reflect current risk–benefit assessments, leaving critics to wonder if caution has finally given way to progress.
FDA adds strongest warning to Sarepta gene therapy linked to 2 patient deaths
go - The Food and Drug Administration is adding a new warning to a gene therapy linked to two patient deaths earlier this year
AI Summary: The FDA has revised the label for Sarepta’s Duchenne muscular dystrophy gene therapy, adding a boxed safety warning and stricter usage conditions following reports of two patient deaths. The update reflects mounting safety concerns that have prompted closer regulatory oversight.
Infant Formula Recall Expands as Botulism Outbreak Grows
Rylee Kirk / nytimes - Federal health officials said caregivers should stop using all ByHeart powdered formula products after 15 infants in 12 states were hospitalized.
AI Summary: ByHeart, a maker of organic baby formula, has expanded its nationwide recall after several infants were hospitalized with botulism symptoms. Federal health officials are urging caregivers to stop using all ByHeart powdered formula as investigations into the contamination continue.
Richard Pazdur Appointed Director of the FDA’s Drug Center: A New Chapter for Cancer Regulation
oncodaily - Dr. Richard Pazdur, one of the most influential figures in oncology drug regulation, has been appointed Director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and […]
AI Summary: The FDA has ushered in a new era in oncology drug oversight by appointing Dr. Richard Pazdur as the director of its Drug Center. The move comes amid agency challenges and staff cuts, promising stabilizing leadership at one of its most influential divisions.