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 ...