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March 14, 2024 15:11 ET | Source: Spherix Global Insights

IgA Nephropathy Pipeline Dynamics Signal Further Treatment Evolution on the Horizon

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...
February 23, 2024 07:05 ET | Source: Travere Therapeutics, Inc.

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

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 ...
September 18, 2023 12:05 ET | Source: AB Science

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

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...
September 18, 2023 12:05 ET | Source: AB Science

AB Science provides an update on the EMA timetable for examination of the masitinib marketing authorization application in ALS

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 ...
August 30, 2023 10:00 ET | Source: BioNTech SE

Pfizer und BioNTech erhalten positive CHMP-Empfehlung für an Omikron XBB.1.5 angepassten COVID-19-Impfstoff in der Europäischen Union

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...
August 30, 2023 10:00 ET | Source: BioNTech SE

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron XBB.1.5-adapted COVID-19 Vaccine in the European Union

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...
December 16, 2022 07:15 ET | Source: uniQure Inc.

uniQure announces positive CHMP opinion for etranacogene dezaparvovec – gene therapy for adults with hemophilia B

LEXINGTON, Mass. and AMSTERDAM, Dec. 16, 2022 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical...
November 10, 2022 09:45 ET | Source: BioNTech SE

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

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...
November 10, 2022 09:45 ET | Source: BioNTech SE

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

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...
October 19, 2022 11:45 ET | Source: BioNTech SE

Pfizer and BioNTech Receive Positive CHMP Opinion for COMIRNATY® in Children 6 Months to less than 5 Years in the European Union

NEW YORK and MAINZ, Germany, October 19, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for...