FDA says it will receive until 10/30 joint applications from drug manufacturers and qualified research institutions to be one of 8-10 applicants chose...
CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device reviews and regulatory decisions to streamline their ...
FDA warns Bausch and Lomb about CGMP violations at its Tampa, FL, drug manufacturing facility.
AstraZeneca says that its Etcamah (camizestrant) failed to significantly improve progression-free survival in the Phase 3 SERENA-4 trial testing the o...
Saint Louis University law professor Michael S. Sinha says FDAs next commissioner should focus on rebuilding the agencys depleted workforce, restoring...
FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.
FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency mi...
FDAs approval of Outlook Therapeutics Lytenava shows that the agencys willingness to accept one adequate and well-controlled trial plus confirmatory e...
