FDA grants an emergency use authorization to Swedish Orphan Biovitrum for its Kineret to treat some adults hospitalized with Covid-19.
Federal Register notice: FDA cancels an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (nir...
FDA releases the form FDA-483 issued following an inspection at the Lupin manufacturing facility in Pune, Maharashtra, India.
FDA releases the form FDA-483 issued following an inspection at Ledgewood, NJ-based Imprimis Rx NJ.
Federal Register notice: FDA announces a 12/7-8 virtual public meeting entitled Drug Supply Chain Security Act Implementation and Readiness Efforts fo...
Washington Legal Foundation says the DC Circuit federal court should grant summary judgment in favor of a Vanda Pharmaceuticals suit seeking to compel...
FDA clears a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage triage and notification product.
An FDA advisory committee votes 8 to 5 to recommend against an emergency use authorization for Verus investigational prostate cancer drug VERU-111 (sa...
