Sen Susan Collins and a bipartisan group of her colleagues introduce the Creating Hope Reauthorization Act to extend until 2030 the FDA priority revie...
A University of Illinois Chicago College of Pharmacy petition calls on FDA to authorize a new form of monograph for biological products.
3D Communications shares the results from its survey of FDA advisory committee members on committee reform issues.
FDA clears a Surgical Planning Associates 510(k) for its new HipInsight 2.0 mixed-reality guidance system for hip arthroplasty.
FDA removes a partial clinical hold on Stoke Therapeutics zorevunersen (STK-001) and its use in children and adolescents with Dravet syndrome.
FDA gives BioVie the go-ahead to begin its Phase 2 SUNRISE-PD trial in Parkinsons disease patients.
Abiomed recalls (Class 1) certain Impella CP with SmartAssist heart pumps after nine devices in a single lot failed inspection.
FDA awards Kyverna Therapeutics a regenerative medicine advanced therapy designation for the companys CAR T-cell product candidate, KYV-101, and its u...
