FDA commissioner Robert Califf says the agency has launched a drug overdose prevention framework with four overarching priorities.
FDA lifts a partial clinical hold on Curis TakeAim Leukemia study that is intended to evaluate emavusertib in a monotherapy phase of the trial.
Hamilton Medical recalls its Hamilton-C6 Intensive Care Ventilator after customer complaints were received about a hardware issue with the ventilators...
Outlook Therapeutics resubmits to FDA a BLA for its ONS-5010 to treat wet age-related macular degeneration.
FDA warns San Diego, CA-based Green Wave Analytical about CGMP and other violations in its work as a contract testing laboratory for drug products and...
FDA grants priority review for a Sanofi BLA for efanesoctocog alfa to treat hemophilia A.
Federal Register notice: FDA announces that Eli Lilly used a priority review voucher for the approval of its NDA for Mounjaro (tirzepatide), a once-we...
Federal Register notice: FDA announces an Emergency Use Authorization issued 7/13 to Novavax, Inc. for its Novavax Covid19 Vaccine.
