FDA red and green lights: July 2025
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
Approvals come for Regeneron and Dizal, but Roche and Replimune see knockbacks.
The company starts a China phase 3 of andamertinib in EGFR-mutant, Met-amplified NSCLC.
Meanwhile, Tango tries again in PRMT5.
Dizal and Daiichi have set the bar, but a lack of other interest in ITK inhibition could ring alarm bells.
Imbruvica faces challenges on multiple fronts.
MorphoSys, Blueprint and Syndax celebrate a successful ASH; Cogent not so much.
Dizal got a lucky break with golidocitinib, and now mid-stage data back the project’s activity in T-cell lymphoma.
The upcoming ASH conference will feature rival datasets from inhibitors of Menin, KIT, EZH1/2, BTK, BET, BCR/ABL and more.