News

A panel selected by FDA Commissioner Marty Makary, MD, MPH, unanimously urged the agency to remove the boxed warning on ...
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 ...
Shares of Sarepta Therapeutics (NASDAQ:SRPT) continued to fall on Friday as Reuters reported that the U.S. FDA plans to ...
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 meeting held by the FDA Thursday spotlighted debate over black box warnings that have limited use of hormone treatment for ...