WebJul 23, 2024 · The FDA now offers four paths for expedited development and/or review, which can be used singly or in conjunction with each other: fast track, breakthrough therapy, priority review, and accelerated approval. In 2024, 18 of the 46 approved novel drugs (39%) had fast track designation namely ocrelizumab for multiple sclerosis, … Web1 day ago · FDA greenlights advancement of SAB-176 Phase 2b trial and manufacturing approach to address influenza strain change. SAB-176 is the first fully-human broadly neutralizing immunoglobulin antibody therapeutic intended to prevent or reduce severe outcomes of Type A and Type B influenza infection in patients at high risk for severe …
Veru (VERU) Up on FDA
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SAB Biotherapeutics Granted Fast Track Designation from FDA for …
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