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…

ByDipanshu DixitJuly 21, 2026

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Shots: The CHMP has recommended Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.); If approved, authorization would be valid in all 30 EEA states Opinion was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I…

ByRidhi RastogiJune 29, 2026

Neurogene Reports Interim P-I/II Trial Results on NGN-401 to Treat Pediatric Patients with Rett Syndrome

Shots: Neurogene has reported interim data from the pediatric cohort (4-10yrs.) of the ongoing P-I/II trial assessing NGN-401 for the treatment of females with Rett syndrome As of Oct 30, 2025, all pediatric pts (n=8) had functional gains across Rett syndrome domains, achieving 35 developmental milestones in fine motor, communication & ambulation. These gains were…

ByRidhi RastogiNovember 13, 2025

EMA Marketing Authorization of New Drugs in June 2026

Acadia Pharmaceuticals’ Daybu (Trofinetide) Receives the CHMP Positive Opinion for Rett Syndrome

Neurogene Reports Interim P-I/II Trial Results on NGN-401 to Treat Pediatric Patients with Rett Syndrome

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