Keeping Track: US FDA's Rejection Of First RMAT BLA Blemishes Otherwise Positive Week Of Non-Oncology News
The latest non-oncology drug development news and highlights from our US FDA Performance Tracker.
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Keeping Track: First COVID Vaccine BLA Kicks Off; Oncology Submissions From Hutchmed, Takeda And Shorla
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Viiv Healthcare's marketing application for fostemsavir started off being fast-tracked through the review process at the European Medicines Agency in January but is now being reviewed under standard timelines. The product is being developed for the treatment of adults with multidrug resistant HIV-1 infection.
The company presented positive data from a Phase III pivotal trial during the American Burn Association virtual annual meeting.