The sNDA for the first-line use of this combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found the combination improved overall survival ...

The approval was based on the HRR gene-mutated (HRRm) population of TALAPRO-2, a randomized, double-blind trial that randomly assigned 1,035 patients with mCRPC to receive enzalutamide with either ...

Recombinant DNA (rDNA) refers to artificial DNA molecules that are created by combining genetic material from different sources. This technology involves the insertion of DNA fragments from one ...

--Astellas Pharma Inc. today announced the submission of a Supplemental New Drug Application on January 31 to Japan's Ministry of Health, Labour and Welfare for PADCEV™ with KEYTRUDA ® as a ...