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Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths
Gene therapy maker Sarepta tells FDA it won't halt shipments despite patient deaths - Drugmaker Sarepta Therapeutics says it won’t comply with a request from U.S. regulators to halt all shipments of i ...
MedPage Today1d
Remove Boxed Warning on Hormone Therapy for Menopause, FDA Panel Says
A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
Sarepta plunges as FDA is reportedly evaluating if gene therapy should remain on market
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped to a new 52-week low on Friday, triggering a trading halt after Bloomberg News reported that the FDA is reviewing whether the company’s gene therapy ...
Sarepta shares plunge 30% as future of its gene therapy appears at risk
Shares of Sarepta Therapeutics plunged more than 30% on Friday as the future of its key gene therapy treatment appeared at risk. The Food and Drug Administration will request that the company ...
FDA Is Investigating If Sarepta’s Gene Therapy Should Stay on Market
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Medical Marketing & Media1d
Rx Rundown: Sarep­ta Ther­a­peu­tics, Juul, Pfizer and more
Sino Biopharma will acquire LaNova Medicines, which has licensed cancer drugs for Merck and AstraZeneca, for $951 million.
Axios on MSN1d
FDA panel backs menopausal hormone therapy
An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for ...
FDA chief: HRT warning among ‘greatest mistakes of modern medicine’
( NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the ...
TAG24 on MSN1d
Food and Drug Administration may soon revise hormone replacement therapy warnings
US Food and Drug Administration Commissioner Marty Makary signaled Thursday that he is open to revising strict warning labels ...
FDA considers changing HRT warning, among 'greatest mistakes' in medicine: Commissioner | Elizabeth Vargas Reports
The FDA is reevaluating longtime warnings on hormone replacement therapy products for menopausal women. Some advocates for change say the so-called “black box” that lists health risks is discouraging ...