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.
Federal Register notice: FDA announces a 9/13 advisory committee meeting to discuss an Intercept Pharmaceuticals supplemental NDA for Ocaliva (obetich...
Federal Register notice: FDA announces a 10/16 public meeting entitled Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub.
