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 ...

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

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 ...

Both Talzenna and Xtandi are FDA-approved. Xtandi is co-marketed by Pfizer (PFE) and Astellas (OTCPK:ALPMF).

Pfizer (NYSE ... then he has no place at FDA under the strong leadership of Secretary Kennedy,” a spokesperson at HHS said. His resignation marks another setback for vaccine makers, particularly ...

This isn't the first setback for Pfizer's danuglipron, either. The company scrapped development of its twice-daily weight-loss pill in 2023 after a clinical trial showed "high rates" of adverse ...

Pfizer said it plans to share the results with global health authorities to potentially update Talzenna's label. The FDA had also approved AstraZeneca's Lynparza in combination with hormone ...

Pfizer Inc. failed ... broaden the approval of Talzenna, a pill currently cleared for a group of patients with prostate cancer that has specific genetic mutations. The FDA isn’t required to ...