Dr. Infante on the Next Step in Melanoma Research

UroGen submitted an NDA for UGN-103 in recurrent NMIBC, T-DXd improved PFS in first-line HER2-mutant lung cancer, and more.

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in August 2026 spanning tumor types.

The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.

The regulatory path to approval for RP1 plus nivolumab in anti–PD-1–pretreated melanoma ran through 3 BLAs, 2 CRLs, and a divided advisory committee vote.