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

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

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

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

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

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

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

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

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

Prices of newly launched drugs in the U.S. have more than doubled from 2021 to 2024, driven by rare disease therapies, ...

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