Senator Marco Rubio (R-FL) urges FDA to take immediate action against two pharmaceutical companies based in Chinas Xinjiang region that allegedly use ...
A FDA advisory committee votes against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) for adults with Type 1 diabet...
FDA backpedals on safety warnings it required on CAR-T cell therapies related to secondary cancers, according to CBER director Peter Marks.
The DC federal court tosses a Jazz Pharmaceuticals suit against FDA over the agencys approval of Avadels narcolepsy drug Lumryz before the end of the ...
Federal Register notice: FDA makes available a final guidance entitled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms and a supplem...
FDA reminds drug compounders to only use ingredients that are suitable for compounding drugs intended to be sterile.
FDA announces extended use dates for some Baxter parenteral products to ease supply issues caused when a Baxter North Carolina facility was hit by Hur...
FDA warns that Chemigroup France is marketing Skin-Cap aerosol spray products that may contain undisclosed steroids.
