The FDA approved the poly ADP ribose polymerase (PARP) inhibitor in June 2023 in combination with enzalutamide for men with ...

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

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

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

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

A group of independent experts voted unanimously that Pfizer didn’t present convincing data to broaden the approval of Talzenna, a pill currently cleared for a group of patients with prostate ...

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

In Pfizer’s case, the New York pharma is trying to expand its PARP inhibitor Talzenna into first-line treatment of metastatic castration-resistant prostate cancer (mCRPC) for patients without ...

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