ROSEN, A LEADING NATIONAL FIRM, Encourages Spectrum Pharmaceuticals, Inc. Investors with Losses in Excess of $100K to Secure Counsel Before Important Deadline in Securities Class Action – SPPI
01 sept. 2021 15h56 HE
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The Rosen Law Firm PA
NEW YORK, Sept. 01, 2021 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, announces the filing of a class action lawsuit on behalf of purchasers of the securities of...
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
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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...
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
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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-BioNTech COVID-19 Vaccine COMIRNATY® Receives Full U.S. FDA Approval for Individuals 16 Years and Older
23 août 2021 11h55 HE
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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...
BioStem Technologies, Inc., Announces the Engagement of Biologics Consulting To Support FDA Strategies and Submissions.
27 juil. 2021 09h00 HE
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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
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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 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...
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....
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...