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Drug Review Europe Approvals

GW Pharma Among Myriad Hopefuls Seeking Extended Indications In EU

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Executive Summary

Applications to widen the therapeutic indications of up to 20 approved drugs will be decided on this week at the European Medicines Agency.

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First Oral Treatment For Spinal Muscular Atrophy Gets EMA Nod

New treatments for advanced endometrial cancer and hereditary angioedema are among six drugs that have just been recommended for EU-wide approval. Harmonized EU advice has also been issued in relation to an investigational antibody combination for treating COVID-19.

GSK's Belantamab Among Drugs Seeking EU Approval Nod

GlaxoSmithKline's potential multiple myeloma treatment is one of several new products that could get an EU marketing thumbs up from the European Medicines Agency this week.

New EU Approvals

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Genmab/AbbVie’s Tepkinly, for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.

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