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...
Reuters reports that CDER acting director Tracey Beth Hoeg is expected to leave the agency just days after the resignation of former FDA commissioner ...
Democratic leaders on the House Energy and Commerce Committee accuse HHS secretary Robert F. Kennedy Jr. of suppressing scientific research supporting...
FDAs recent rejection of an experimental melanoma treatment becomes a flashpoint in broader criticism of former FDA commissioner Marty Makary and the ...
FDA issues an early alert warning healthcare providers about a potentially high-risk problem involving certain anesthesia workstations manufactured by...
FDA approves Genentechs Tecentriq (atezolizumab) and a subcutaneous formulation of the drug for the adjuvant treatment of certain patients with muscle...
FDA says Sun Pharma has recalled one batch of doxorubicin HCl liposome injection due to glass particles found in some vials during production.