An updated Class 1 recall notice says Hamilton Medical is recommending that certain coaxial breathing circuit sets used with HAMILTON-C1, HAMILTON T-1...
FDA accepts for priority review a Belite Bio NDA for tinlarebant for treating Stargardt Disease Type 1.
A petition submitted to FDA calls for the agency to create conditional nonprescription access to albuterol sulfate inhalers.
President Trump signs an executive order directing the federal government to develop what the White House calls "Gold Standard Childhood Vaccine Recom...
Tenax Therapeutics says its oral levosimendan candidate TNX-103 failed to meet the primary endpoint in a Phase 3 trial evaluating the treatment in pat...
FDA sends ITM Isotope Technologies Munich SE a Complete Response Letter (CRL) for its investigational radiopharmaceutical for gastroenteropancreatic n...
Abiomed and manufacturing partner Oscor issue a correction (Class 1 recall) for certain catheter introducers used with Impella heart pumps after ident...
FDA appoints Sarah Ibrahim as CDER deputy center director for Regulatory Programs, a role she has been serving in an acting capacity since January.
