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...
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.
Federal Register notice: FDA withdraws an 8/2 notice that sought comments on a proposed information collection entitled Risk/Safety Considerations and...
After receiving a complete response letter, Lykos Therapeutics says it will pursue FDAs dispute resolution process to question the need for another st...
