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
August 25, 2021 12:10 ET | BioNTech SE
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 profileSARS-CoV-2 neutralizing...
Pfizer und BioNTech leiten den Einreichungsprozess einer ergänzenden Biologics License Application bei der FDA für die Zulassung einer Auffrischungsimpfung mit COMIRNATY ® bei Personen ab 16 Jahren ein
August 25, 2021 12:10 ET | BioNTech SE
Neue Daten der Phase-3-Studie zeigen, dass eine Auffrischungsimpfung (dritte Dosis) mit dem COVID-19-Impfstoff von Pfizer und BioNTech signifikante neutralisierende Antikörpertiter gegen SARS-CoV-2...
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Pfizer-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older
August 23, 2021 11:55 ET | BioNTech SE
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 safety data after second doseMore than 1.2...
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PRVB BREAKING ALERT: ROSEN, RECOGNIZED INVESTOR COUNSEL, Encourages Provention Bio, Inc. Investors with Losses to Secure Counsel Before Important Deadline – PRVB
June 04, 2021 19:15 ET | The Rosen Law Firm PA
NEW YORK, June 04, 2021 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Provention Bio, Inc. (NASDAQ: PRVB) between November 2,...
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Immunocore Reports First Quarter 2021 Financial Results
May 12, 2021 07:00 ET | Immunocore Holdings Limited
PRESS RELEASE Immunocore Reports First Quarter 2021 Financial Results Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected to be completed in...
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
May 07, 2021 06:45 ET | BioNTech SE
NEW YORK and MAINZ, GERMANY, May 7, 2021 (GLOBE NEWSWIRE) — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S....
Pfizer und BioNTech beginnen rollierenden Einreichungsprozess einer Biologics License Application für die volle Zulassung ihres COVID-19-Impfstoffs bei der FDA
May 07, 2021 06:45 ET | BioNTech SE
NEW YORK, USA und MAINZ, DEUTSCHLAND, 07. Mai 2021 —Pfizer Inc. (NYSE: PFE) und BioNTech SE (Nasdaq: BNTX) gaben heute bekannt, dass sie die Einreichung des Antrags für die vollständige Zulassung...
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Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
February 10, 2021 16:05 ET | Genmab A/S
Company Announcement Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology Virtual Congress 2020 COPENHAGEN, Denmark and BOTHELL,...
ROSEN, TRUSTED INVESTOR COUNSEL, Reminds BioMarin Pharmaceutical Inc. Investors of Important Deadline in Securities Class Action – BMRN
October 25, 2020 12:42 ET | The Rosen Law Firm PA
NEW YORK, Oct. 25, 2020 (GLOBE NEWSWIRE) -- Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) between February...
ElsaLys Biotech announces submission of Biologics License Application to FDA for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease in adult patients
July 23, 2020 08:00 ET | Elsalys Biotech
ElsaLys Biotech announces submission of Biologics License Application to FDA for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease in adult patients        ·The Biologics License...