20/11/2025 Taiho and Cullinan initiated the rolling submission of a NDA for zipalertinib in EGFR-mutant NSCLC ( Ref ) Taiho and Cullinan Therapeutics have initiated the rolling submission of a NDA to the US FDA seeking accelerated approval of zipalertinib (EGFR tyrosine kinase inhibitor) for the treatment of patients with locally advanced or metastatic NSCLC with EGFR ex20ins mutations who have previously received platinum-based systemic chemotherapy. The submission is based

06/08/2025 Jazz Pharmaceuticals' Modeyso received accelerated approval from the FDA for Recurrent H3 K27M-mutant Diffuse Midline Glioma (...

05/08/2025 Immutep received positive feedback from the FDA for the late-stage development of Eftilagimod Alfa in SCCHN ( Ref ) Immutep...

02/07/2025 Lynozyfic received accelerated approval from the US FDA for R/R Multiple Myeloma ( Ref ) Regeneron Pharmaceuticals announced...

23/06/2025 Datroway has been approved in the US for locally advanced or metastatic EGFR-mutated NSCLC ( Ref ) The US FDA approved...