Merck reports that its Phase 3 TroFuse-005 trial evaluating the investigational antibody-drug conjugate sacituzumab tirumotecan met its primary endpoi...
A legal analysis reviews how an FDA guidance issued last year is reshaping how pharmaceutical and medical device companies can communicate scientific ...
DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary is unlikely to result in major changes to the agenc...
Two prominent drug-policy scholars sharply criticize former FDA commissioner Marty Makary in a Health Affairs commentary, arguing that his tenure weak...
FDA replaces the acting leaders of CDER and CBER following the resignation of former commissioner Marty Makary.
FDA approves AstraZenecas Baxfendy (baxdrostat), an aldosterone synthase inhibitor for adults with hypertension whose blood pressure remains uncontrol...
FDA places a clinical hold on an Aardvark Therapeutics clinical trial on its experimental metabolic drug ARD-101 based on a cardiac safety issue.
The U.S. Supreme Court temporarily preserves nationwide access to the abortion pill mifepristone by mail, blocking a lower court ruling that would hav...
