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 ...

If this EUA application is authorised, children 6 months to under 5 years of age would receive a primary series consisting of two 3-µg doses of the original Pfizer/BioNTech COVID-19 Vaccine ...

Pfizer’s anti-TFPI antibody marstacimab has been approved by the FDA to treat haemophilia, becoming the pharma group’s second new therapy for the blood disorder this year. Marstacimab will be ...

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.