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Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

06/12/2022 MaP 0

PDF Version Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the companies have submitted an application to the U.S. Food and […]

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

20/10/2022 MaP 0

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) […]

Pfizer and BioNTech Submit Application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine

22/08/2022 MaP 0

Data support request for Emergency Use Authorization of a 30-µg booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age […]

Pfizer and BioNTech Announce U.S. FDA Approval of their COVID-19 Vaccine COMIRNATY®

08/07/2022 MaP 0

… For Adolescents 12 through 15 Years of Age COMIRNATY® is the first and only COVID-19 vaccine to be granted FDA approval for adolescents 12 […]

Pfizer and BioNTech Submit a Variation to EMA

08/07/2022 MaP 0

…. for the Vaccination of Children Ages 6 Months to less than 5 Years with COMIRNATY® Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: […]

Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age

17/06/2022 MaP 0

In a Phase 2/3 clinical trial, the Pfizer-BioNTech COVID-19 Vaccine elicited a strong immune response in this age group Three 3-µg doses had favorable safety […]

Pfizer and BioNTech Initiate Rolling Submission for Emergency Use Authorization of Their COVID-19 Vaccine in Children 6 Months Through 4 Years of Age Following Request from U.S. FDA

01/02/2022 MaP 0

With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy […]

Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine

06/01/2022 MaP 0

Third mRNA vaccine collaboration between the companies aims to accelerate development of an improved vaccine for shingles, a debilitating, disfiguring and painful disease that affects […]

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older

03/01/2022 MaP 0

First emergency use authorization in the United States for a COVID-19 vaccine booster in adolescents 12 through 15 years of age Today’s FDA action also […]

Pfizer and BioNTech Submit Updated Longer-Term Follow-Up Data of COMIRNATY® in Adolescents 12 Through 15 Years of Age to EMA

23/12/2021 MaP 0

In the trial, a two-dose series of COMIRNATY (30-µg per dose) was 100% effective (95% confidence interval [CI, 87.5, 100.0]) against COVID-19, measured seven days […]

Pfizer And BioNTech Submit Supplemental Biologics License Application for U.S. FDA Approval of COMIRNATY® in Adolescents 12 Through 15 Years of Age

17/12/2021 MaP 0

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and […]

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 16 Years and Older

10/12/2021 MaP 0

PDF Version First emergency use authorization in the United States for a COVID-19 vaccine booster in individuals 16 years and older Pfizer Inc. (NYSE: PFE) […]

Pfizer and BioNTech Provide Update on Omicron Variant

09/12/2021 MaP 0

Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage), while two doses show significantly reduced neutralization […]

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union

25/11/2021 MaP 0

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 […]

Pfizer and BioNTech Submit Request to Amend U.S. FDA Emergency Use Authorization of Their COVID-19 Vaccine Booster to Include All Individuals 18 and Older

10/11/2021 MaP 0

Submission is based on efficacy and safety data from a Phase 3 randomized, controlled trial with more than 10,000 participants Data show a favorable safety […]

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  • SciBase and Schweiger Dermatology Group partner to advance skin cancer detection in select New Jersey locations

    29/03/2023 0
  • BioNTech Announces New ADS Repurchase Program

    28/03/2023 0
  • Merck Announces Expanded Partnership with Beyond Benign to Increase Global Access to Green Chemistry Education

    27/03/2023 0
  • Bayer expands global clinical program for darolutamide in prostate cancer

    23/03/2023 0
  • Sandoz receives US FDA approval for biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation

    21/03/2023 0
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