FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.
FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equinoxe Reverse Shoulder...
FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...
Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept significantly reduced protei...
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.
