News

Fierce Pharma3d
FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population
In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...
BioSpace3d
Pfizer’s Talzenna Expansion Fails To Earn FDA Advisory Committee’s Support
The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...
Pfizer bid to expand Talzenna use in prostate cancer questioned by FDA panel
A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its ...
FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study
An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.
pharmaphorum3d
Mixed outcomes for pharma in big week for FDA adcomms
For J&J, there was a positive outcome as the Oncologic Drugs Advisory Committee (ODAC) voted six to two in favour of approval ...
Bloomberg L.P.4d
Pfizer Hits FDA Setback in Effort to Boost Prostate Cancer Drug
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 ...
BioPharma Dive4d
FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study
Today, a brief rundown of news involving Pfizer and Sarepta Therapeutics, as well as updates from UroGen Pharma, Altos Labs and BioNTech that you may have missed. BioNTech will invest up to £1 billion ...