InflaRx Receives Positive CHMP Opinion for GOHIBIC® (Vilobelimab) for the Treatment of SARS-CoV-2-Induced Acute Respiratory Distress Syndrome
15. November 2024 07:51 ET
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InflaRx N.V.
JENA, Germany, Nov. 15, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics targeting the complement system, today announced...
CHMP adopts positive opinion recommending approval of new and expanded indications for SPEVIGO®
29. Juli 2024 02:05 ET
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Boehringer Ingelheim
The CHMP positive opinion is based on the EFFISAYIL® 2 trial, which showed that no flares were observed after week 4 of SPEVIGO® administered subcutaneously. During the 48-week trial, an 84% reduction...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für an Omikron JN.1 angepassten COVID-19-Impfstoff in der Europäischen Union
27. Juni 2024 10:30 ET
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BioNTech SE
Der aktualisierte COVID-19-Impfstoff ist auf die Omikron JN.1-Sublinie von SARS-CoV-2 zugeschnitten und wird für Personen ab 6 Monaten empfohlenDie Beurteilung basiert auf präklinischen und...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European Union
27. Juni 2024 10:30 ET
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BioNTech SE
The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and olderRecommendation is based on pre-clinical and...
IgA Nephropathy Pipeline Dynamics Signal Further Treatment Evolution on the Horizon
14. März 2024 15:11 ET
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Spherix Global Insights
EXTON, PA, March 14, 2024 (GLOBE NEWSWIRE) -- The past several years have brought a transformative shift to the IgA nephropathy (IgAN) treatment landscape, including the introduction of two new...
Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy
23. Februar 2024 07:05 ET
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Travere Therapeutics, Inc.
Committee for Medicinal Products for Human Use (CHMP) recommends approval of the conditional marketing authorization (CMA) for sparsentan for the treatment of IgA nephropathy (IgAN) in Europe ...
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
18. September 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...
AB Science provides an update on the EMA timetable for examination of the masitinib marketing authorization application in ALS
18. September 2023 12:05 ET
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AB Science
PRESS RELEASE AB SCIENCE PROVIDES AN UPDATE ON THE EUROPEAN MEDICINES AGENCY'S TIMETABLE FOR EXAMINATION OF THE MARKETING AUTHORIZATION APPLICATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS ...
Pfizer und BioNTech erhalten positive CHMP-Empfehlung für an Omikron XBB.1.5 angepassten COVID-19-Impfstoff in der Europäischen Union
30. August 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
30. August 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...