Press Release Archive

 
10.15.2021 - Pfizer’s Abrocitinib Receives Positive CHMP Opinion for the Treatment of Adults with Moderate to Severe Atopic Dermatitis
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  • CHMP also recommends XELJANZ® (tofacitinib) approval for the treatment of adults with active ankylosing spondylitis

NEW YORK--(BUSINESS WIRE)--

 
09.28.2021 - Valneva and Pfizer Report Further Positive Phase 2 Results, Including Booster Response, for Lyme Disease Vaccine Candidate

Saint-Herblain (France) and New York (United States), September 28, 2021Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, and Pfizer Inc. (NYSE: PFE), today announced further positive Phase 2 results, including booster response, for Lyme disease vaccine candidate VLA15.

 
09.28.2021 - Pfizer and BioNTech Submit Initial Data to U.S. FDA From Pivotal Trial of COVID-19 Vaccine in Children 5 to <12 Years of Age
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Formal submission to request Emergency Use Authorization to follow in the coming weeks

 
09.27.2021 - Pfizer Starts Study of mRNA-Based Next Generation Flu Vaccine Program
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  • Influenza results in approximately 5 million cases of severe illness and 290,000 to up to 650,000 deaths worldwide every year,1 with current seasonal vaccines preventing 40% to 60% of the disease in the best-matched seasons 2
  • mRNA-based vaccin
 
09.27.2021 - Pfizer Starts Global Phase 2/3 EPIC-PEP Study of Novel COVID-19 Oral Antiviral Candidate for Post-Exposure Prophylaxis in Adults
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  • EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) is the third study launched in this global clinical research program.
  • New study
 
09.24.2021 - Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency

NEW YORK, NY and MIAMI, FL September 24, 2021 - Pfizer Inc. (NYSE: PFE) and OPKO Health Inc. (NASDAQ: OPK) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD) in pediatric patients.

 
09.23.2021 - Pfizer Invites Public to View and Listen to Webcast of Pfizer November 2 Conference Call with Analysts
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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, November 2, 2021.

 
09.23.2021 - Pfizer Declares Fourth-Quarter 2021 Dividend
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Board of Directors approves quarterly cash dividend of $0.39 per share

 
09.22.2021 - Pfizer and BioNTech Expand Collaboration with U.S. to Provide 500 Million Additional COVID-19 Vaccine Doses at Not-for-Profit Price for Donation to Poorest Countries
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  • Expanded agreement brings the total number of COVID-19 vaccine doses to be supplied to the U.S.
 
09.20.2021 - Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference
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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and CEO, at the Cantor Global Healthcare Conference on Monday, September 27, 2021 at 12:10 p.m. Eastern Daylight Time.

 
09.20.2021 - Pfizer and BioNTech Announce Positive Topline Results From Pivotal Trial of COVID-19 Vaccine in Children 5 to 11 Years
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  • Results are the first from a pivotal trial of any COVID-19 vaccine in children under 12 years of age
  • In participants 5 to 11 years of age, the vaccine was safe,
 
09.17.2021 - FDA Advisory Committee Votes Unanimously in Favor Of COMIRNATY® Booster for Emergency Use in People 65 and Older and Certain High-risk Populations
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  • Committee reviewed clinical data showing a booster dose of COMIRNATY® elicits high neutralization titers against SARS-CoV-2 and all currently tested variants
 
09.17.2021 - Astellas’ and Pfizer’s XTANDI® (enzalutamide) Reduced Risk of Death by 34% in Men with Metastatic Hormone-Sensitive Prostate Cancer in Phase 3 ARCHES Study

Late-breaking abstract to be presented September 18 during European Society for Medical Oncology Congress 2021 

 
09.09.2021 - Myovant Sciences and Pfizer Announce FDA Acceptance of Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated With Endometriosis
  • Filing in endometriosis is supported by data from the Phase 3 SPIRIT program
  • FDA PDUFA target action date is May 6, 2022 

BASEL, Switzerland and NEW YORK, September 9, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for review a supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

 
09.09.2021 - UK’s MHRA Grants Marketing Authorisation for Pfizer’s CIBINQO® (abrocitinib) for Adults and Adolescents With Moderate to Severe Atopic Dermatitis
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-Abrocitinib is a once-daily oral JAK1 inhibitor indicated in Great Britain for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and over, who are candidates for systemic therapy-

-This is the first marketing authorization globally for abrocitinib-

 
09.07.2021 - Pfizer Invites Public to Listen to Two Webcasts of Pfizer Discussions at Upcoming Healthcare Conferences
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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to two webcasts of discussions with Pfizer executives at two upcoming healthcare conferences.

 
09.02.2021 - Pfizer Announces Start of Phase 3 Clinical Trial in Adults for Its Investigational Vaccine Against Respiratory Syncytial Virus (RSV)
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  • First subjects vaccinated in study of Pfizer’s RSV bivalent prefusion F subunit investigational vaccine candidate in adults ages 60 or older
  • RSV is a common and pervasive cause of severe acute respiratory illness in

Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.