Pfizer and BioNTech
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
25 août 2021 12h10 HE | 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
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
25 août 2021 12h10 HE | 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
23 août 2021 11h55 HE | 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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BioStem Technologies, Inc., Announces the Engagement of Biologics Consulting To Support FDA Strategies and Submissions.
27 juil. 2021 09h00 HE | BioStem Technologies, Inc.
Pompano Beach, Fl., July 27, 2021 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC PINK: BSEM) ("BioStem" or the "Company"), a pre-clinical-stage biotechnology company focused on harnessing...
ContraFect Appoints Gary Woodnutt, Ph.D. as Senior Vice President of Translational Sciences and Preclinical Development
17 juin 2021 07h31 HE | ContraFect Corporation
YONKERS, N.Y., June 17, 2021 (GLOBE NEWSWIRE) -- ContraFect Corporation (Nasdaq:CFRX), a late clinical-stage biotechnology company focused on the discovery and development of direct lytic agents...
Pfizer and BioNTech
Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for U.S. FDA Approval of their COVID-19 Vaccine
07 mai 2021 06h45 HE | 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
Pfizer und BioNTech beginnen rollierenden Einreichungsprozess einer Biologics License Application für die volle Zulassung ihres COVID-19-Impfstoffs bei der FDA
07 mai 2021 06h45 HE | 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...
ContraFect Announces BARDA Contract Award for Up to $86.8 Million and Provides Business Outlook
11 mars 2021 16h05 HE | ContraFect Corporation
BARDA to provide funding for the ongoing Phase 3 DISRUPT study of exebacase for the treatment of patients with Staph aureus bloodstream infections Results from the Phase 3 DISRUPT study interim...
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Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review
17 févr. 2021 07h30 HE | Coherus BioSciences, Inc.
REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) has...
Genmab and Seagen Submit Tisotumab Vedotin Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical Cancer
10 févr. 2021 16h05 HE | 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,...