FDA warns Japans Sato Pharmaceutical Co. about CGMP violations in its production of finished over-the-counter drugs.
The U.S. government urges the Supreme Court to reject an appeal by a Texas compounding pharmacy in a closely watched case over whether federal drug la...
Outlook Therapeutics wins an appeal with FDA over its BLA for ONS-5010/Lytenava (bevacizumab-vikg), clearing a potential path toward U.S. approval of ...
FDA investigators cite major quality control and data integrity concerns at an Indian manufacturing facility operated by Intas Pharmaceuticals.
Dyne Therapeutics submits a BLA that seeks accelerated approval for its experimental Duchenne muscular dystrophy therapy z-rostudirsen.
FDA Matters founder Steven Grossman explains why he thinks it will take the Trump administration at least until the end of the year to name a new FDA ...
Senator Tom Cotton (R-AR) urges FDA and government cybersecurity officials to review Chinese-made medical devices cleared before updated cybersecurity...
Biogen and Denali Therapeutics limit the development of their experimental Parkinsons disease drug BIIB122 after the therapy failed to meet primary an...
