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...
ContraFect_LOGO_Web.jpg
ContraFect Announces BARDA Contract Award for Up to $86.8 Million and Provides Business Outlook
March 11, 2021 16:05 ET | 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 BioSciences, Inc. logo
Coherus BLA Filing for Adalimumab Biosimilar Candidate Accepted by FDA for Review
February 17, 2021 07:30 ET | 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...
logo.jpg
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,...
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...
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
July 23, 2020 08:00 ET | 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...
15-SORRENTO-Therapeutics-Logo-FINAL.png
Sorrento Announces Filing for Approval of Infliximab Biobetter Antibody by Its Partner Mabpharm in China
January 06, 2020 07:00 ET | 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-Vertical-Logo.png
VBI Vaccines Announces Positive Top-Line Results from PROTECT, a Pivotal Phase 3 Study of Sci-B-Vac®
June 17, 2019 06:00 ET | 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...