Sorry, you need to enable JavaScript to visit this website.

Pfizer Receives Positive CHMP Opinion for Conversion of PAXLOVID™ Conditional Marketing Authorization to Full Marketing Authorization in the European Union

New York, NY, January 27, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended converting the conditional Marketing Authorization (cMA) for PAXLOVIDTM (nirmatrelvir tablets and ritonavir tablets) to standard (also referred to as “full”) Marketing Authorization (MA) for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Pfizer to Acquire Sanford, North Carolina Manufacturing Site from Abzena

NEW YORK & SAN DIEGO, January 17, 2023 – Pfizer Inc. (NYSE: PFE) and Abzena today announced that the companies have entered into an agreement under which Pfizer will acquire Abzena’s manufacturing facility in Sanford, North Carolina. Upon completion of the construction, the state-of-the-art facility will have extensive capabilities for producing biologics drug substance and provides additional manufacturing capacity allowing Pfizer to help accelerate its innovative pipeline. In addition, Abzena and Pfizer’s CentreOne contract manufacturing organization will seek to collaborate to advance complex biologic products to market.

U.S. FDA Extends Review of Pfizer’s New Drug Application for PAXLOVID™

  • Pfizer oral treatment remains available to eligible U.S. patients under Emergency Use Authorization as a critical tool in the fight against COVID-19

NEW YORK, December 20, 2022 -- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets).

Pfizer to Provide U.S. Government with an Additional 3.7 Million Treatment Courses of PAXLOVID™ to Help Combat COVID-19

NEW YORK, December 13, 2022 -- Pfizer Inc. (NYSE: PFE) has reached an agreement with the U.S. Government for the purchase of an additional 3.7 million treatment courses of its authorized COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). This purchase supplements the 20 million treatment courses previously contracted by and already delivered to the U.S. Government. The additional 3.7 million treatment courses are planned for delivery by early 2023. 

Pfizer and BioNTech Receive U.S. FDA Fast Track Designation for Single-Dose mRNA-Based Vaccine Candidate Against COVID-19 and Influenza

NEW YORK and MAINZ, GERMANY, DECEMBER 9, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection.

Subscribe to Updates