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Sarepta’s Risky Gamble: Gene Therapy Stays on Market Despite FDA Request
The FDA called for Sarepta Therapeutics to stop shipping its muscular dystrophy gene therapy, but the company said no.
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"Obsolete And Unnecessary": FDA Set To Revoke 52 Nutrition And Labeling Rules
The FDA plans to revoke 52 outdated nutrition and labeling regulations to streamline food industry standards, citing them as ...
Which companies have agreed to drop artificial food dyes?
(NEXSTAR) — Dozens of companies that make ice cream and frozen dairy desserts announced on Monday that they would remove artificial food dyes from their products by 2028, marking yet another voluntary ...
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Sarepta Tells FDA It Won’t Stop Shipments Despite Patient Deaths
Sarepta Therapeutics announced late Friday evening that it will not comply with the Food and Drug Administration's ...
Sarepta tells FDA it won’t halt shipments despite patient deaths
In a highly unusual move, Cambridge-based Sarepta said late Friday won’t comply with a request from the Food and Drug ...
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 its gene ...
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FDA chief: HRT warning among ‘greatest mistakes of modern medicine’
FDA Commissioner Marty Makary, whose agency convened a panel of experts earlier in the day to discuss the topic, told ...
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A 'Culture Change' Is Needed in Academic Medicine, FDA Commissioner Says
The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...
F.D.A. Panelists Call for Removal of Warnings on Menopause Treatments
Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...
Live coverage: FDA’s Makary talks animal testing phase-out at Hill Nation Summit
Nearly six months into President Trump’s second term, The Hill and NewsNation team up to host the inaugural Hill Nation ...
FDA Commissioner Marty Makary Says The FDA Is 'Now Revising' Saturated Fat Guidelines
During a press conference on Monday, Food and Drug Administration Commissioner Marty Makary spoke about the agency's ...
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FDA Commissioner Marty Makary Proposes Lowering Industry User Fees
According to Makary, reducing user fees—which make up just under half of the FDA's budget—could make it easier for smaller ...