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INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
22 hours ago

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NEWS

Tanabe Pharma Report the EC Approval of Onerji for Parkinson’s Disease (PD) 

Shots:  The EC has approved Onerji (levodopa/carbidopa) infusion for advanced PD pts with uncontrolled motor fluctuations. The therapy is being developed by its wholly owned subsidiary, NeuroDerm   Approval was based on the global P-III (BouNDless) trial, which demonstrated Onerji + supplemental oral LD/CD significantly increased ON time without troublesome dyskinesia and reduced OFF time vs immediate-release oral LD/CD. Favourable long-term safety and tolerability results were also observed in the…
April 27, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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