source
- FDA grants accelerated approval to Replimune’s melanoma therapy Tudriqev after two prior rejectionsThe Food and Drug Administration has granted accelerated approval to Replimune’s RP1 treatment, which will be marketed under the name Tudriqev, for patients with advanced melanoma. An advisory com…
- 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…