FDA approves changes to labeling for two Hedgehog inhibitors covering musculoskeletal adverse reactions and creatine kinase monitoring as requested in...
FDA publishes a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices.
BrainStorm Cell Therapeutics says it has refiled a BLA under the agencys file-over-protest procedure for NurOwn, a stem cell therapy for treating amyo...
FDA says that it is now resuming generic in-person face-to-face meetings with generic drug industry members in a phased-in approach while also allowin...
FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based Path...
FDA clears a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds.
Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certain patients with adva...
Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.
