Press Release Archive

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
08.30.2021 - Positive Top-Line Results From Pfizer’s Phase 3 JADE DARE Trial Comparing the Efficacy of Abrocitinib and Dupilumab for Moderate to Severe Atopic Dermatitis
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-JADE DARE trial met co-primary and key secondary endpoints and demonstrated a safety profile consistent with previous studies-

08.26.2021 - Pfizer Announces New Chief Business Innovation Officer
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NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) today announced that Aamir Malik has joined the company as Executive Vice President and Chief Business Innovation Officer. Mr. Malik will be a member of Pfizer’s Executive Leadership Team reporting to Chairman and Chief Executive Officer, Albert Bourla. Mr.

08.26.2021 - Pfizer and BioNTech Announce Collaboration With Brazil’s Eurofarma to Manufacture COVID-19 Vaccine Doses for Latin America
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NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc.

08.25.2021 - Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of COMIRNATY® in Individuals 16 and Older
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  • New Phase 3 data show booster (third) dose of COMIRNATY induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile
08.23.2021 - Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older
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  • COMIRNATY is the first COVID-19 vaccine to be granted FDA approval
  • Approval is based on a comprehensive submission package including six-month efficacy and safe
08.23.2021 - Pfizer to Acquire Trillium Therapeutics Inc.
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Proposed acquisition strengthens Pfizer’s category leadership in Oncology with addition of next-generation, investigational immuno-therapeutics for hematological malignancies

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.