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.
The Trump administration considers an executive order addressing vaccines and autism as soon as next week.
Senators Jim Banks (R-IN) ) and Cory Booker (D-NJ) introduce the bipartisan Prescription Information Modernization Act to allow drug makers to distrib...
FDA's announces a 9/23 advisory committee meeting to vote on a Grail PMA for the Galleri test and its use in the early detection of multiple cancers.