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- FDA accepts first Keytruda biosimilar application as Merck faces looming patent cliffThe U.S. Food and Drug Administration has accepted the first publicly announced filing for a Keytruda biosimilar, identified as FYB206, which could receive approval as early as the third quarter of…
- FDA accepts review of Biohaven’s ataxia drug, boosting shares as ArriVent’s lung cancer trial miss drags its stock downBiohaven saw its shares jump after the FDA agreed to review its rare‑disease drug for spinocerebellar ataxia. The regulator’s decision lifted the stock by roughly 25% in late October, offering the…