June 19, 2025

Mutant ROS1 inhibitor FDA approval

FOCUS on Drug Approvals. On June 11th, the FDA approved Taletrectinib (Ibtrozi, Nuvation Bio Inc) for adults with locally advanced or metastatic, ROS1-positive, non-small cell lung […]
March 6, 2025

PI3Kalpha inhibitor in the news

Focus on Drug Discovery. Lilly will acquire Scorpion Therapeutics’ PI3Kalpha inhibitor program which includes STX-478, a potentially best-in-class mutant-selective PI3Kα inhibitor currently being evaluated in a […]
February 19, 2025

Tyrosine kinase drug approval

FOCUS on New Drug Approvals. Last Friday the FDA granted full approval of Deciphera’s Romvimza™ (Vimseltinib) for the treatment of symptomatic tenosynovial giant cell tumor (TGCT) […]
February 14, 2025

MEK inhbitor drug approval

FOCUS on New Drug Approvals. Yesterday the FDA approved SpringWorks Therapeutics‘ Mirdametinib (PD-325901) for the treatment of patients with neurofibromatosis type 1 with symptomatic plexiform neurofibromas […]
December 19, 2024

ALK inhibitor FDA approval

Focus on Drug Approvals. This week the FDA approved Ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer. Ensartinib is a potent and specific […]
August 20, 2024

Tyrosine kinase inhibitor clinical approval

Drug Approval News: The FDA has approved JNJ’s Rybrevant® (Amivantamab-vmjw plus Lazertinib) as a first line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer. Lazertinib […]