[ Price : $8.95]
FDA warns Marcus Research Laboratory about CGMP deviations in its production of active pharmaceutical ingredients.[ Price : $8.95]
FDA sends Revance Therapeutics a complete response letter on its BLA for daxibotulinumtoxinA for Injection, indicated for treating...[ Price : $8.95]
FDA issues Omeros a complete response letter on its BLA for narsoplimab as a treatment for hematopoietic stem cell transplant-asso...[ Price : $8.95]
FDA reminds in vitro diagnostic manufacturers that the agency requires an institutional review board review for all device clinica...[ Price : $8.95]
United Therapeutics receives an FDA complete response letter on its NDA for Tyvaso DPI (treprostinil) for treating pulmonary arter...[ Price : $8.95]
FDA approves a Boehringer Ingelheim supplemental BLA for Cyltezo (adalimumab-adbm), an interchangeablebiosimilar that will allow p...[ Price : $8.95]
FDA grants HistoSonics a breakthrough device designation for its novel sonic (acoustic energy) beam therapy histotripsy and its us...[ Price : $8.95]
FDA Review posts the Federal Register notices for the week ending 10/15/2021.