FDA says Insulet has issued a correction for its Omnipod DASH personal diabetes managers due to issues with the batteries.
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.
