BioNTech Receives Priority Medicines (PRIME) Designation from EMA for Enhanced Regulatory Support of CAR-T Candidate BNT211 in Testicular Cancer
June 23, 2022 11:00 ET
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BioNTech SE
First BioNTech product candidate to receive priority medicines (PRIME) designation by the European Medicines Agency for enhanced regulatory support facilitating the clinical development of the...
Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1618 for the Treatment of Phenylketonuria
May 24, 2022 07:00 ET
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Synlogic, Inc.
CAMBRIDGE, Mass., May 24, 2022 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), a clinical-stage biotechnology company developing medicines for metabolic and immunological diseases through its...
BioRestorative Therapies Announces cGMP Cell Manufacturing Facility Certification
April 04, 2022 08:00 ET
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BioRestorative Therapies, Inc
Certification Gives BioRestorative Therapies Clinical Grade Manufacturing Capabilities MELVILLE, N.Y., April 04, 2022 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (the “Company” or...
Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19
December 17, 2021 08:16 ET
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Vir Biotechnology, Inc.
LONDON and SAN FRANCISCO, Dec. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für COMIRNATY® bei Kindern von 5 bis unter 12 Jahren in der Europäischen Union
November 25, 2021 07:30 ET
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BioNTech SE
NEW YORK, USA und MAINZ, Deutschland, 25. November 2021—Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel...
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union
November 25, 2021 07:30 ET
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BioNTech SE
NEW YORK and MAINZ, Germany, November 25, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für COVID-19-Auffrischungsimpfung in der Europäischen Union
October 04, 2021 12:10 ET
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BioNTech SE
NEW YORK, USA und MAINZ, Deutschland, 4. Oktober 2021—Pfizer Inc. (NYSE: PFE, „Pfizer“) und BioNTech SE (Nasdaq: BNTX, „BioNTech“) gaben heute bekannt, dass der Ausschuss für Humanarzneimittel...
Pfizer and BioNTech Receive CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union
October 04, 2021 12:10 ET
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BioNTech SE
NEW YORK and MAINZ, Germany, October 4, 2021—Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced that the Committee for Medicinal Products for Human Use (CHMP)...
Celsion and Hainan Poly Pharm Sign Agreement to Manufacture Celsion’s DNA-based Vaccine
September 17, 2021 09:00 ET
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Celsion CORP
Expands GEN-1 Program Collaboration to Add Clinical and Commercial Batches of Investigational Vaccine LAWRENCEVILLE, N.J. and HAINAN, China, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Celsion Corporation...
Pfizer und BioNTech erhalten erste EU-Zulassung eines COVID-19-Impfstoffs für Jugendliche in der EU
May 28, 2021 15:45 ET
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BioNTech SE
NEW YORK, USA und MAINZ, DEUTSCHLAND, 28. Mai 2021 — Pfizer Inc. (NYSE: PFE) und BioNTech SE (Nasdaq: BNTX) gaben heute bekannt, dass die bedingte Marktzulassung (Conditional Marketing Authorization,...