FDA resumes posting drug rejection letters, underscoring transparency push

The FDA posted 14 new complete response letters (CRLs) for drug applications after a three-month pause on real-time CRL disclosure. Highlights include Grace Therapeutics’ nimodipine injectable for aneurysmal subarachnoid hemorrhage and a third anti-PD-1/VEGFR combo rejection by Hengrui/Elevar. The pause followed a citizen petition, with the disclosure policy tied to a broader transparency effort championed by Health Secretary Kennedy Jr. and former FDA Commissioner Makary. Earlier waves of CRLs and ongoing efforts to formalize disclosure—including proposed rule changes and potential FD&C Act amendments—have framed the push for real-time CRL release.