• Read more about Pfizer and BioNTech Receive Positive CHMP Opinion for COVID-19 Vaccine Booster in Adolescents 12 through 17 Years of Age in the European Union

NEW YORK AND MAINZ, GERMANY, February 24, 2022 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion on the administrat

• Read more about FDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) InterchangeabilityFDA Accepts for Review Pfizer’s Supplemental Application for ABRILADA™ (adalimumab-afzb) Interchangeability

NEW YORK, February 25, 2022 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Prior Approval Supplement (PAS) to the Biologics License Application (BLA) for ABRILADA™ (adalimumab-afzb) as an interchangeable biosimilar to Humira® (adalimumab). The Biosimilar User Fee Act (BsUFA) goal date for an FDA decision is in Q4 2022.

• Read more about Pfizer and BioNTech Submit for U.S. Emergency Use Authorization of an Additional Booster Dose of their COVID-19 Vaccine for Older Adults

•    Submission based on real-world safety and efficacy data from Israel 
•    Data showed rates of confirmed infections were 2 times lower and rates of severe illness were 4 times lower among individuals who received an additional booster dose of Pfizer-BioNTech COVID-19 Vaccine compared to individuals who received only an initial booster

• Read more about Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., March 21,2022.

• Read more about Three Year Follow-Up Data from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) Confirm Prolonged Progression-Free Survival in First-Line ALK-Positive Advanced Lung Cancer

NEW YORK, NY, April 8, 2022 – Pfizer Inc. (NYSE: PFE) announced updated results from the Phase 3 CROWN trial, which evaluated LORBRENA® (lorlatinib, available in Europe under the brand name LORVIQUA) versus XALKORI® (crizotinib) in people with previously untreated anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

• Read more about Pfizer Voluntary Nationwide Recall of Lots of ACCUPRIL® (Quinapril HCl) Due to N-Nitroso-Quinapril Content

FOR IMMEDIATE RELEASE - NEW YORK, NY., April 22,2022.

Pfizer is voluntarily recalling five (5) lots of Accupril (Quinapril HCl) tablets distributed by Pfizer to the patient (consumer/user) level due to the presence of a nitrosamine, N-nitroso-quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. 

• Read more about Pfizer and BioNTech Submit Application for U.S. Emergency Use Authorization for a COVID-19 Vaccine Booster Dose in Children 5 Through 11 Years of Age

NEW YORK and MAINZ, GERMANY, APRIL 26, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of a 10-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age (also referred to as children ages 5 through <12). 

• Read more about Pfizer to Open First U.S. Sites in Phase 3 Trial of Investigational Gene Therapy for Ambulatory Patients with Duchenne Muscular Dystrophy

-- Regulatory authorities in United Kingdom, Canada, Taiwan, Spain and Belgium approve re-start of global Phase 3 CIFFREO study; additional reviews ongoing -- 

• Read more about Pfizer Shares Top-Line Results from Phase 2/3 EPIC-PEP Study of PAXLOVID™ for Post-Exposure Prophylactic Use

NEW YORK, April 29, 2022 -- Pfizer Inc. (NYSE: PFE) today shared top-line results from the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study evaluating PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for post-exposure prophylactic use.

• Read more about Pfizer Presents Positive Real-World Evidence for First-Line IBRANCE® (palbociclib) Combination Therapy in HR+, HER2- Metastatic Breast Cancer at ESMO Breast Cancer 2022

NEW YORK, NY, May 4, 2022 – Pfizer Inc. (NYSE:PFE) announced today the presentation of real-world evidence demonstrating an associated benefit for patients treated with IBRANCE® (palbociclib) in combination with an aromatase inhibitor (AI), as compared to AI alone, in the first-line setting, at the European Society for Medical Oncology (ESMO) Breast Cancer 2022 Congress.