AB Science fait une mise au point sur le calendrier de l’EMA concernant l'examen de la demande d'autorisation de mise sur le marché du masitinib dans la SLA
September 18, 2023 12:05 ET
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AB Science
COMMUNIQUE DE PRESSE AB SCIENCE FAIT LE POINT SUR LE CALENDRIER DE L'AGENCE EUROPÉENNE DES MÉDICAMENTS CONCERNANT L'EXAMEN DE LA DEMANDE D'AUTORISATION DE MISE SUR LE MARCHÉ DU MASITINIB DANS LA...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für an Omikron XBB.1.5 angepassten COVID-19-Impfstoff in der Europäischen Union
August 30, 2023 10:00 ET
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BioNTech SE
Der aktualisierte COVID-19-Impfstoff ist auf die Omikron XBB.1.5-Sublinie von SARS-CoV-2 zugeschnitten und wird für Personen ab 6 Monaten empfohlenDie Beurteilung basiert auf präklinischen Daten, die...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union
August 30, 2023 10:00 ET
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BioNTech SE
The updated COVID-19 vaccine is tailored to the Omicron XBB.1.5 sublineage of SARS-CoV-2 and is recommended for individuals 6 months of age and olderRecommendation is based on pre-clinical data...
InflaRx’s Marketing Authorization Application (MAA) for Vilobelimab for Treatment of Critically Ill COVID-19 Patients under Review by European Medicines Agency (EMA)
August 30, 2023 07:30 ET
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InflaRx N.V.
MAA for vilobelimab was submitted in JulyMAA has been validated by EMA and is now under reviewRegulatory submission based on pivotal data from PANAMO Phase III trialCompany announces attendance at...
European Commission Grants Orphan Drug Designation for aTyr Pharma’s Efzofitimod for Treatment of Systemic Sclerosis
June 22, 2023 08:00 ET
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aTyr Pharma, Inc.
SAN DIEGO, June 22, 2023 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE), a biotherapeutics company engaged in the discovery and development of first-in-class medicines from its proprietary...
Synlogic Reports Fourth Quarter and Full Year 2022 Financial Results and Corporate Updates
March 29, 2023 06:40 ET
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Synlogic, Inc.
– Phenylketonuria (PKU) program on track for Phase 3 trial initiation in first half of 2023 – – Rare Pediatric Disease Designation granted for SYNB1934 for PKU and SYNB1353 for homocystinuria (HCU)...
Synlogic Receives Positive Opinion on Orphan Designation from the European Medicines Agency for SYNB1934 for the Treatment of Phenylketonuria
March 28, 2023 06:52 ET
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Synlogic, Inc.
CAMBRIDGE, Mass., March 28, 2023 (GLOBE NEWSWIRE) -- Synlogic, Inc. (Nasdaq: SYBX), the leading company advancing therapeutics based on synthetic biology, today announced that the European Medicines...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für Auffrischungsimpfung mit an Omikron BA.4/BA.5 angepasstem bivalenten COVID-19-Impfstoff für Kinder im Alter von 5 bis 11 Jahren in der Europäischen Union
November 10, 2022 09:45 ET
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BioNTech SE
NEW YORK und MAINZ, Deutschland, 10. November 2022 — 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 Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine Booster for Children 5 Through 11 Years of Age in European Union
November 10, 2022 09:45 ET
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BioNTech SE
NEW YORK and MAINZ, GERMANY, November 10, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine...
Pfizer and BioNTech Receive Positive CHMP Opinion for Conversion of COMIRNATY® Conditional Marketing Authorization to Full Marketing Authorization in the European Union
September 16, 2022 08:00 ET
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BioNTech SE
Standard marketing authorization recommendation applies to all indications and formulations in the European Union, including COMIRNATY® Original/Omicron BA.4-5 and COMIRNATY® Original/Omicron BA.1...