The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to ...

A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its ...

One possible explanation for the gap is the availability of highly efficacious CAR-T therapies in the U.S. and Europe serving ...

“Pfizer is dedicated ... expand the approved label for TALZENNA. TALZENNA in combination with XTANDI was approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult ...

Both Talzenna and Xtandi are FDA-approved. Xtandi is co-marketed by Pfizer (PFE) and Astellas (OTCPK:ALPMF).

Pfizer’s prostate cancer therapy Talzenna, when combined with Xtandi, can extend overall survival (OS) by nearly nine months over the standard of care (SoC), according to a Phase III trial.

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 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 ...

“Pfizer is dedicated to advancing ... Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. Myelodysplastic Syndrome/Acute Myeloid Leukemia (MDS/AML), including ...