Genmab to Submit Biologics License Application to U.S. Food and Drug Administration for Epcoritamab (DuoBody®-CD3xCD20) for the Treatment of Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
June 30, 2022 14:24 ET
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Genmab A/S
Company Announcement COPENHAGEN, Denmark; June 30, 2022 – Genmab A/S (Nasdaq: GMAB) today announced its intent to submit a biologics license application (BLA) to the U.S. Food and Drug...
Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma
January 26, 2022 07:00 ET
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Immunocore Holdings Limited
Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanomaKIMMTRAK is the first and only FDA approved therapy for the treatment of...
RVNC INVESTOR NOTICE: ROSEN, TRUSTED NATIONAL TRIAL COUNSEL, Encourages Revance Therapeutics, Inc. Investors with Losses to Secure Counsel Before Important Deadline in Securities Class Action – RVNC
December 16, 2021 17:15 ET
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The Rosen Law Firm PA
WHY: NEW YORK, Dec. 16, 2021 (GLOBE NEWSWIRE) -- 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
August 25, 2021 12:10 ET
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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
August 25, 2021 12:10 ET
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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
August 23, 2021 11:55 ET
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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...
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
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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,...
Immunocore Reports First Quarter 2021 Financial Results
May 12, 2021 07:00 ET
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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 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
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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
May 07, 2021 06:45 ET
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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....