The FDA’s Oncologic Drugs Advisory Committee (ODAC) is planning to host its first meeting under new agency commissioner Marty Makary, M.D. As head of the FDA’s oncology department, Richard ...

Kennedy Jr., a longtime vaccine critic who has campaigned for the president on promises to shake up the FDA, as the new secretary of Health and Human Services Department. At Pfizer, she will be an ...

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

The results have been shared with global health authorities, including the FDA and the European Medicines Agency (EMA), to support potential updates to the approved labels for TALZENNA.

(RTTNews) - Pfizer Inc. (PFE ... compared to Xtandi alone. Talzenna in combination with Xtandi is already approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult ...

NEW YORK, October 10, 2024--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) today announced positive topline results from the final prespecified overall survival (OS) analysis of the TALAPRO-2 study of ...

The Food and Drug Administration (FDA) announced Thursday the approval of both Pfizer’s and Moderna’s updated COVID-19 vaccines for the 2024-2025 respiratory viral season. The updated vaccines ...

“The Board should not allow Moderna to opportunistically embrace prior art before the FDA but now distance itself from the same prior art here.” – Pfizer’s brief to PTAB In a recent brief ...

Aug 21 (Reuters) - The U.S. Food and Drug Administration on Monday approved Pfizer's (PFE.N), opens new tab respiratory syncytial virus (RSV) vaccine for use in women during the middle of the ...

(The Hill) – The ongoing drug shortages impacting the U.S. are now threatening to exhaust two commonly used forms of penicillin, Pfizer said in a warning to the Food and Drug Administration (FDA ...

The approval comes less than a month after the FDA approved a similar shot by rival GSK Plc (GSK.L), opens new tab. Pfizer's vaccine was approved for people aged 60 and older, the company said ...