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A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its ...
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 ...
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 ...
NEW YORK, February 13, 2025--Pfizer Inc. (NYSE: PFE) today announced positive results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP ...
Pfizer hopes a unique life-extension benefit for its Talzenna can serve to further expand the drug’s already broadest-in-class U.S. label in prostate cancer. Following an FDA approval in 2023 ...
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 ...
TALZENNA + XTANDI is the first PARP inhibitor plus ARPI combination to demonstrate statistically significant and clinically meaningful improvement in overall survival (OS) in patients with ...
Pfizer beats EPS estimates for the 12th quarter. Explore PFE's oncology success, cost-cutting impact, and why it's rated a ...
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