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
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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
07 mai 2021 06h45 HE
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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
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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...
Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review
17 févr. 2021 07h30 HE
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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
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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,...
ElsaLys Biotech announces submission of Biologics License Application to FDA for LEUKOTAC® (inolimomab) for the treatment of graft-versus-host disease in adult patients
23 juil. 2020 08h00 HE
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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...
ElsaLys Biotech annonce l'acceptation par la FDA du dépôt de sa demande de mise sur le marché pour LEUKOTAC® (inolimomab) pour le traitement de la maladie du greffon contre l'hôte chez l’adulte
23 juil. 2020 08h00 HE
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Elsalys Biotech
ElsaLys Biotech annonce l'acceptation par la FDA du dépôt de sa demande de mise sur le marché pour LEUKOTAC® (inolimomab) pour le traitement de la maladie du greffon contre l'hôte chez l’adulte...
Sorrento Announces Filing for Approval of Infliximab Biobetter Antibody by Its Partner Mabpharm in China
06 janv. 2020 07h00 HE
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Sorrento Therapeutics, Inc.
SAN DIEGO, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics (Nasdaq: SRNE) announced today that its partner Mabpharm (HK:2181) filed recently a New Drug Application for the Infliximab...
VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac®
17 juin 2019 06h00 HE
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VBI Vaccines, Inc.
Both co-primary endpoints successfully met – including non-inferiority in all adults age ≥18 years, and superiority in adults age ≥ 45 yearsSeroprotection rates four weeks post-3rd vaccination of...