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News about "US FDA review"
FYB206 Becomes First Keytruda Biosimilar to Get US FDA Review
The US FDA has accepted FYB206’s Biologics License Application (BLA) for review, marking the first publicly announced Keytruda biosimilar filing acceptance.
US FDA Review | 13/10/2026 | By News Bureau
Teva Plans Acquisition of Novel Neuroscience Product
Teva plans to acquire BXCL501, a novel dexmedetomidine sublingual film under the US Food and Drug Administration (FDA) review for potential at-home treatment of acute agitation in adults with schizophrenia or bipolar disorder.
US FDA Review | 01/09/2026 | By News Bureau
Fresenius Wins US FDA and EMA Review Acceptance for Vedolizumab Biosimilar
Fresenius has secured US Food and Drug Administration (FDA) and European Medicines Agency (EMA) review acceptance for its vedolizumab biosimilar, targeting Ulcerative Colitis (UC) and Crohn's Disease (CD) in adults.
US FDA Review | 03/08/2026 | By News Bureau | 605
GSK Enters Agreement to Acquire Nuvalent
GSK has agreed to acquire Nuvalent in a multi-product oncology deal that strengthens its lung cancer portfolio with two late-stage, potential best-in-class therapies—zidesamtinib and neladalkib—for non-small cell lung cancer.
US FDA Review | 10/06/2026 | By News Bureau | 326
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
US FDA Review | 10/03/2026 | By News Bureau | 220
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