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Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19
17 déc. 2021 08h16 HE | 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...
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ObsEva Announces Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids
17 déc. 2021 07h00 HE | ObsEva SA
-European Commission Decision Anticipated in Q1 2022- -CHMP recommendation follows the recent acceptance of the linzagolix uterine fibroids NDA by the U.S. Food and Drug Administration-   Ad hoc...
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ObsEva Announces Positive CHMP Opinion for Linzagolix, an Oral GnRH Antagonist, for the Treatment of Uterine Fibroids
17 déc. 2021 01h00 HE | ObsEva SA
-European Commission Decision Anticipated in Q1 2022- -CHMP recommendation follows the recent acceptance of the linzagolix uterine fibroids NDA by the U.S. Food and Drug Administration-   Ad hoc...
Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 5 to under 12 Years of Age in the European Union
25 nov. 2021 07h30 HE | 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 COMIRNATY® bei Kindern von 5 bis unter 12 Jahren in der Europäischen Union
25 nov. 2021 07h30 HE | 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 CHMP Positive Opinion for COVID-19 Vaccine Booster in the European Union
04 oct. 2021 12h10 HE | 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)...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für COVID-19-Auffrischungsimpfung in der Europäischen Union
04 oct. 2021 12h10 HE | 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 First Authorization in European Union for COVID-19 Vaccine in Adolescents
28 mai 2021 15h45 HE | BioNTech SE
NEW YORK and MAINZ, GERMANY, May 28, 2021 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY® in the European...
Pfizer und BioNTech erhalten erste EU-Zulassung eines COVID-19-Impfstoffs für Jugendliche in der EU
28 mai 2021 15h45 HE | 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,...
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ONTOZRY™ (cenobamate) receives positive CHMP opinion for the adjunctive treatment of uncontrolled focal onset seizures in adults*
29 janv. 2021 12h20 HE | Arvelle Therapeutics
Positive CHMP opinion is an important milestone for Arvelle Therapeutics and cenobamate When approved, cenobamate will provide new hope in helping adult patients with uncontrolled focal epilepsy move...