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- Replimune secures FDA accelerated approval for melanoma therapy after two prior rejectionsReplimune, a biotech based in Massachusetts, has received accelerated approval from the U.S. Food and Drug Administration for its melanoma drug. The approval comes after the therapy was rejected tw…
- FDA approves Takeda’s orexin-2 drug Orzeyful for narcolepsy type 1The U.S. Food and Drug Administration has approved Takeda Pharmaceutical's new sleep medication, Orzeyful, marking the first product in the emerging orexin‑2 drug class. Orzeyful works by amplifyi…