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 ...

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

The ODAC deemed the results from TALAPRO-2 are not sufficient to conclude a favorable benefit-risk profile for adding ...

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 ...

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

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

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