FDA accepts for review a Capricor Therapeutics BLA resubmission for its experimental cell therapy deramiocel, intended to treat heart complications in...
FDA approves an expanded use of GSKs Wellcovorin (leucovorin calcium) tablets for treating cerebral folate deficiency in adult and pediatric patients....
FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.
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...
