EMA
Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.
Europe is facing one of the biggest pharmaceutical reforms in two decades. Medicines for Europe’s Beata Stepniewska and Adrian van den Hoven outlined how the regulatory trinity – EU pharmaceutical legislation, Critical Medicines Act, and Biotech Act – will reshape the industry.
David Loew highlights the problem that around half of the drugs approved by the European Medicines Agency are not actually launched.
Several orphan drugs, including SOBI’s emapalumab, Merck KGaA’s pimicotinib and Percigen’s zopapogene imadenovec, are now under review for potential pan-EU marketing authorization by the European Medicines Agency.
A marketing authorization application for another AstraZeneca product – its orphan drug candidate anselamimab – is now also under review in the EU.
The CHMP has delivered a negative trend vote on the US firm's filing for Daybue.
The Danish drugmaker is getting ready to celebrate a first-in-class approval from the European Commission for semaglutide for metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including therapies for a serious liver disease and an ultra‑rare genetic mitochondrial disorder.
Generics Bulletin reviews global regulatory developments across the world.
The firm's type 1 diabetes drug has been given the green light by the European Commission.
The European Medicines Agency scheduled oral explanation meetings for Sanofi’s MS drug and two other products nearing the end of their EU regulatory review cycle. These meetings typically give companies a final chance to convince the agency their drugs merit approval.
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.