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....
Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in patients with focal o...
FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.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...
