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EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
3 days ago

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Moderna
NEWS

Moderna Reports the EC Approval of mCOMBRIAX to Protect Against Influenza and COVID-19    

Shots:  The EC has approved mCOMBRIAX (mRNA-1083), a combination vaccine for the prevention of influenza and COVID-19 in patients ≥50 yrs. across all 30 EEA states    Approval was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone / Efluelda (a high dose influenza vaccine )+ Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where all 1EPs were met, demonstrating non-inferiority of immune response with acceptable safety and tolerability    MRNA-1010, Moderna’s…
April 20, 2026

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Moderna
NEWS

Moderna’s mCOMBRIAX Receives the CHMP Positive Opinion to Protect Against Influenza and COVID-19   

Shots:  The CHMP has recommended approval of mCOMBRIAX (mRNA-1083), a combination vaccine for prevention of influenza and COVID-19 in patients ≥50 yrs. If granted, the approval would be valid in all 30 EEA states  Opinion was based on a P-III trial evaluating mRNA-1083 in ~8,000 adults across two cohorts: ≥65yrs (n~4,000) vs co-administered Fluzone High‑Dose / Efluelda + Spikevax and 50–64yrs (n~4,000) vs Fluarix + Spikevax, where…
February 26, 2026

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