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The US FDA New Drug Approvals in May 2025 Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025 The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was AbbVie’s Emrelis securing FDA approval for treating NSCLC With High c-Met Protein Overexpression Company: Verastem Oncology Product: Avmapki + Fakzynja Active Ingredient: Avutometinib + Defactinib Disease: KRAS-Mutated Low-Grade Serous Ovarian Cancer Date: May 08, 2025 Shots: This accelerated approval for the combination of Avmapki (avutometinib) + Fakzynja (defactinib) was granted in advance to the planned PDUFA of Jun 30, 2025, which will be available in the US within a week as a co-pack Approval was based on P-II (RAMP 201) trial assessing Avmapki (3.2mg, twice weekly) + Fakzynja (200 mg, BID) in the above pts (n=57) dosed for first 3wks