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

A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its ...

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

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

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs ...

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 ...

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

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed 8-0 against a new in­di­ca­tion for Pfiz­er’s Talzen­na in ...

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 ...