FDA clears a CS Medical 510(k) for its Ethos Automated Ultrasound Probe Cleaner Disinfector.
FDA lifts a Pharvaris clinical hold on a deucrictibant clinical trial for the on-demand treatment of hereditary angioedema attacks.
Citing potential liver injury concerns, Pfizer says it is terminating the development program for glucagon-like peptide-1 receptor agonist anti-diabet...
CBER director Peter Marks overrides the review team in the 6/22 accelerated approval of Sarepta Therapeutics Duchenne muscular dystrophy gene therapy ...
FDA posts a draft guidance entitled Psychedelic Drugs: Considerations for Clinical Investigations.
The Senate Appropriations Committee approves FDAs appropriations bill, which provides the agency a $20 million spending increase.
FDA sends Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid for treating pre-cirrhotic fibrosis...
FDA posts a final guidance entitled Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding ...
