FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.
FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility.
FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that some devices may ruptur...
The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement action against Hims & H...
Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are likely to run afoul of...
FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.
FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspection findings (not spec...
Consumer advocacy group Public Citizen urges Pfizer to commit to maintaining access to its medicines in Europe after comments by CEO Albert Bourla sug...
