News Related to Acute Myeloid Leukemia

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FDA Approves 46 Novel Drugs in 2025, Small Molecules Lead with 31 Approvals

May 01, 2025

The FDA approved 46 novel drugs in 2025, down from 50 in 2024. Small molecules accounted for 31 approvals (67%), with oncology leading at nine approvals. Large molecules contributed 15 approvals (33%), spanning ADCs, bispecifics, and subcutaneous delivery innovations.

FDA Approves Filkri, Accord BioPharma's Biosimilar to Neupogen

Jan 16, 2026

The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen, for cancer patients at risk of infection due to chemotherapy and other indications. The approval marks Accord BioPharma's sixth biosimilar product.