Four U.S. Representatives introduce the Biologics Competition Act, a bipartisan bill that would order HHS to evaluate the process by which interchange...
GSK says it plans to submit a BLA supplement by 7/1 after reporting interim results from a Phase 3 trial investigating Jemperli (dostarlimab) plus sta...
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.
