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Incyte Corporation: Incyte Announces Positive CHMP Opinion for Ruxolitinib Cream (Opzelura) for the Treatment of Non-segmental Vitiligo in Adults and Adolescents

At approval, ruxolitinib cream will be the first treatment for repigmentation in non-segmental vitiligo available in the European Union (EU) In Europe, there are approximately 1.5 million
United States Dennis Riedl Catalina Loveman Steven Stein Christine Chiou Thierry Passeron

Servier receives a positive CHMP opinion for Tibsovo® in IDH1-mutated Acute Myeloid Leukemia (AML) and Cholangiocarcinoma (CCA) patients

Tibsovo® (ivosidenib tablets) is the first IDH1 inhibitor recommended for approval in Europe The positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studies PARIS, Feb. 24, 2023 /PRNewswire/ -- Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European...
France General Prnewswire Servier Claude Bertrand European Union European Medicines Agency European Commission

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Akebia Receives Positive CHMP Opinion in Europe for Vafseo™ (vadadustat) for the Treatment of Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

CAMBRIDGE, Mass., Feb. 23, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (NASDAQ: AKBA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommendi...
United Kingdom United States Mercedes Carrasco Johnp Butler European Commission Drug Administration

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