Merck says it will meet with regulatory authorities about an expanded indication after reporting Phase 3 trial results of Keytruda in certain endometr...
The leadership of the House Energy and Commerce Committee and two of its subcommittees asks FDA for detailed drug shortage information about 10 specif...
Federal Register notice: FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...
Federal Register notice: FDA makes available a final guidance entitled General Considerations for Animal Studies Intended to Evaluate Medical Devices....
The chair and ranking member of the House Energy and Commerce Health subcommittee ask CBER director Peter Marks for detailed information on FDA clinic...
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...
