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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.[ Price : $8.95]
Former FDA associate commissioner Peter Pitts says FDA needs a deputy commissioner for regulatory competitiveness to aggressively ...[ Price : $8.95]
FDA provides an update on its ongoing monitoring of heater-cooler devices and the risk of nontuberculous mycobacteria infections i...