Taletrectinib

Drug

Related News

FDA Reviews Updated Taletrectinib Data in Advanced ROS1-Positive NSCLC

May 11, 2026

The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.

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.