FDA sends Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection, indicated for treating frown lines, due to...
FDA issues Omeros a complete response letter on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-associated thrombotic mi...
FDA reminds in vitro diagnostic manufacturers that the agency requires an institutional review board review for all device clinical investigations tha...
United Therapeutics receives an FDA complete response letter on its NDA for Tyvaso DPI (treprostinil) for treating pulmonary arterial hypertension and...
FDA Review posts the Federal Register notices for the week ending 10/15/2021.
FDA Review posts product approval summaries for the week ending 10/15/2021.
Lupin recalls all irbesartan and irbesartan/hydrochlorothiazide tablets after finding some active pharmaceutical ingredient batches were above the spe...