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Incyte receives positive CHMP opinion for Opzelura in moderate atopic dermatitis

Incyte (NASDAQ:INCY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending approval of Opzelura (ruxolitinib) cream for the treatment of moderate atopic dermatitis in adult patients for whom topical corticosteroids and topical calcineurin inhibitors are inadequate or inappropriate.

Leia mais: Incyte receives positive CHMP opinion for Opzelura in moderate atopic dermatitis
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Datroway receives positive CHMP opinion for first-line TNBC in EU

Daiichi Sankyo and AstraZeneca (NYSE:AZN) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for Datroway (datopotamab deruxtecan) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

Leia mais: Datroway receives positive CHMP opinion for first-line TNBC in EU
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Acadia Pharmaceuticals receives positive CHMP opinion for DAYBU

Acadia Pharmaceuticals (NASDAQ:ACAD) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older.

Leia mais: Acadia Pharmaceuticals receives positive CHMP opinion for DAYBU