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Committee for Medicinal Products for Human Use (CHMP)

RNAi therapeutics company, Alnylam Pharmaceuticals, has revealed that the CHMP has adopted a positive opinion on the use of patisiran for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or 2 polyneuropathy Read more

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A gene therapy for the treatment of adolescent and adult patients with transfusion-dependent β-Thalassemia (TDT) is granted an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Read more

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Janssen’s Darzalex (daratumumab) as a frontline treatment. Read more

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Akcea Therapeutics and Ionis Pharmaceuticals have announced that Tegsedi (inotersen) has received European marketing authorisation approval for the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hATTR Read more

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A label change for MSD’s (known as Merck in the US and Canada) ulcerative colitis (UC) treatment — SIMPONI (golimumab) — has received approval from the European Commission. Read more

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Cablivi (caplacizumab) has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the treatment of a rare blood-clotting disorder, acquired thrombotic thrombocytopenic purpura (aTTP) Read more

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Specialty pharmaceutical company, Alliance Pharma, has revealed that following discussions with the MHRA and the CHM, the marketing authorisation application for Diclectin is now considered approvable. Read more

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Akcea Therapeutics, has announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the use of its orphan drug for the treatment of Stage 1 or Stage 2 polyneuropathy in adults with hereditary Read more

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