CHMP

Palovarotene is the first medicine to be submitted for regulatory approval for fibrodysplasia ossificans progressiva (FOP), an ultra-rare disease with an estimated prevalence of 1.36 per million individuals and around 900 people diagnosed…

If approved for Europe, PYLCLARI® (INN: Piflufolastat (18F) formerly known as -DCFPyL) will offer prostate cancer patients access to a diagnostic imaging agent more sensitive than conventional imaging.Proven track record of -DCFPyL…

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Tibsovo® (ivosidenib tablets) is the first IDH1 inhibitor recommended for approval in EuropeThe positive CHMP opinion is based on clinical data from the AGILE (in AML) and ClarIDHy (in CCA) studiesPARIS, Feb. 24, 2023 /PRNewswire/ --…

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Approval by the European Commission would expand the indications of Reblozyl for treatment of anemia in adults with beta thalassemia in Europe In the pivotal BEYOND study, Reblozyl significantly increased hemoglobin levels, which were…

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 needs, announced that its partner,…

The positive CHMP opinion is based on the results of the HAVEN 6 study, which demonstrated effective bleed control and a favourable safety profile of Hemlibra in people with moderate haemophilia A without inhibitors1Given that many…

        CHMP Adopts Positive Opinion Based Upon Complete Review of all Pre-Clinical, Clinical Studies and CMC Data CHMP Recommends Label for Long-Term Enzyme Replacement Therapy in Combination with Miglustat for both ERT-Experienced…