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Jul 12, 2026
Pfizer's ELREXFIO significantly delayed disease progression in a Phase 3 trial for multiple myeloma, outperforming a standard regimen and strengthening the case for earlier use. Separately, Pfizer completed a real-world study of its lung cancer drug lorlatinib in ROS1-positive NSCLC patients.
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.
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.
