The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

Talzenna is currently approved in combination with Xtandi (enzalutamide) for individuals with castration-resistant prostate ...

In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.

Astellas and Pfizer's Xtandi plus ADT showed a decrease in mortality risk in a metastatic hormone-sensitive prostate cancer ...

Pfizer Inc. failed to convince advisers to the US Food and Drug Administration to support a dramatic expansion in the use of ...

One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving ...

For J&J, there was a positive outcome as the Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of approval ...

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

Pfizer’s PARP inhibitor Talzenna has become the first targeted treatment for HER2-negative locally advanced or metastatic breast cancer with BRCA1/2 mutations to be recommended by NICE for ...

Notably, PARP inhibitors have emerged as a major advancement, with AKEEGA (Janssen), TALZENNA (Pfizer/Astellas Pharma), and LYNPARZA (AstraZeneca/Merck) receiving approval for mCRPC in 2023.