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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.
The ODAC deemed the results from TALAPRO-2 are not sufficient to conclude a favorable benefit-risk profile for adding ...
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 ...
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 ...
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 ...
PFE Pfizer Inc Pfizer’s TALZENNA® in Combination with XTANDI® Improves Survival Outcomes in Metastatic Castration Resistant Prostate Cancer TALZENNA + XTANDI is the first PARP inhibitor plus ...
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