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Nuvalent Outlines FDA Timelines for ROS1, ALK Drugs as $1.4B Cash Fuels Global Launch Plans

Feb 15, 2026

Nuvalent provided updates on regulatory milestones for its lead oncology programs, including FDA acceptance of the zidesamtinib NDA with a September PDUFA date and plans to submit an NVL-655 NDA in the first half of 2026.

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.