In a somber end to an FDA advisory committee’s two-day scouring of multiple drugmakers’ oncology data, Pfizer’s pitch to expand Talzenna into a broader prostate cancer population has failed ...

The U.S. Food and Drug Administration (FDA) has ordered Pfizer and Moderna to expand their warning labels on COVID-19 vaccines. The updated warnings highlight a rare risk of heart inflammation in ...

A U.S. FDA panel of independent experts beat back an effort by Pfizer (NYSE:PFE) to expand the patient population for its prostate cancer treatment Talzenna (talazoparib). Members of the Oncologic ...

The FDA isn’t required to follow the votes of its advisers, but typically does. Pfizer is seeking to more than triple the number of people eligible for Talzenna in the US, pointing to a clinical ...

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 ...

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 cancer ...

The former head of the Food and Drug Administration’s (FDA) drug division is joining Pfizer as its chief medical officer, the company announced Monday. Patrizia Cavazzoni was formerly director ...

In mCRPC patients, Talzenna + Xtandi cut death risk by 20% ... gene mutations. Also Read: Pfizer/Astellas Tout Encouraging Data From Keytruda Combo Regime In Urothelial Cancer Showing 49% ...

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 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 ...