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 ...

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 ...

Talzenna is currently approved in combination with Xtandi (enzalutamide) for individuals with castration-resistant prostate ...

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib ...

Talzenna is currently approved in combination with Xtandi (enzalutamide) for individuals with castration-resistant prostate cancer that have the HRR gene mutation. Pfizer submitted an sNDA to have ...

COVID shots should target newer strains of JN.1 variant in 2025-26 campaign, US FDA advisers say U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 ...

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K.

Pfizer has revealed that its much-anticipated ... was the first drug in the oral SERD class to be cleared by the FDA, getting the green light in 2023 as a second-line therapy for HR-positive ...

US Senators are concerned that Pfizer and Eli Lilly's recent forays into direct-to-consumer distribution of medicines via telehealth platforms could violate federal anti-kickback laws. The four ...