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 approves a Boehringer Ingelheim supplemental BLA for Cyltezo (adalimumab-adbm), an interchangeablebiosimilar that will allow pharmacy substitution...
FDA grants HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its use to mechanically de...
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.