European health agency recommends approving Moderna’s combined flu, COVID vaccine

The European Medicines Agency (EMA) announced Friday it has recommended Moderna’s combined mRNA COVID-19 and flu vaccine be ...
PharmTech

Key Regulatory Trends from EMA’s February 2026 CHMP Meeting

The February 2026 meeting of the EMA's Committee for Medicinal Products for Human Use (CHMP) resulted in recommendations for twelve new medicines.¹ These outcomes, which included recommendations for ...
Pharmaceutical Technology

Moderna’s dual Covid-flu vaccine poised for EMA approval on positive CHMP take

If approved, Moderna's mCOMBRIAX would become the first combination Covid-flu jab to gain regulatory approval anywhere across ...
Medscape

EMA Rejects Drugs for Rett Syndrome, Schizophrenia

Daybue was turned down for Rett syndrome, and Iloperidone for schizophrenia and bipolar I, with safety and benefit-risk concerns cited in both cases.
PharmTech

EMA Calls New EU Pharma Legislation Most Significant in Two Decades

The reform grants eight years of regulatory data and market protection, with extensions for drugs addressing unmet needs. EMA's procedures will be streamlined, reducing assessment times and ...