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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.
One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving ...
Both Talzenna and Xtandi are FDA-approved. Xtandi is co-marketed by Pfizer (PFE) and Astellas (OTCPK:ALPMF).
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 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 ...
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