EMA

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.

Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the EU marketing application from the European Medicines Agency for the closely-watched chronic obstructive pulmonary disease drug.

Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the file from the EMA for the closely-watched chronic obstructive pulmonary disease drug.

Finalized EU pharmaceutical legislation must ensure that patients are fairly represented in regulatory decision making, according to patient and industry experts.

Generics manufacturers have succeeded in overturning a decision awarding Biogen an extra year of market exclusivity for its multiple sclerosis brand Tecfidera.

EU trilogs on the new pharmaceutical legislation will finalize the role patients will take in influencing the development of a new definition of unmet medical need.