Novartis says it will seek FDA approval for an expanded use for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), for slowing disease progression in c...
FDA posts a final guidance entitled E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical T...
FDA accepts for review a Protalix BioTherapeutics and Chiesi BLA resubmission for PRX102 (pegunigalsidase alfa) for treating adult patients with Fabry...
Federal Register notice: FDA makes available a revised draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Ge...
FDA issues Verve Therapeutics a formal clinical hold letter that outlines the information required to resolve a hold that was placed 11/4 on VERVE-101...
FDA confirms the survival rate of Abiomeds Impella RP System that was required to undergo a post-approval study after being approved in 2017.
FDA posts a draft guidance entitled ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions.
FDA adds Getinge Maquet/Datascope Intra-Aortic Balloon Pump devices to its device shortage list.
