News

FDA outlines both short-term and long-term goals within the letter. In the short term, FDA plans to create a “centralized, ...
FDA published a press release written by FDA Commissioner Marty Makary that highlighted his efforts to “make food healthier for children and families, accelerate meaningful cures and treatments, and ...
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 ...
A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
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 ...
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 ...
US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from ...
Sino Biopharma will acquire LaNova Medicines, which has licensed cancer drugs for Merck and AstraZeneca, for $951 million.
An Food and Drug Administration expert panel on Thursday endorsed removing the "black box" warning on hormone treatments for ...
( NewsNation) — The head of the U.S. Food and Drug Administration signaled Thursday that he supports changing or removing the ...