Merck & Co has said it will ask the EMA’s human medicines committee (CHMP) to look again at a decision not to recommend approval of its antiviral Lagevrio for treating
The EMA's human medicines committee has started a review of Novartis' sickle cell disease (SCD) therapy Adakveo, shortly after the company reported that it failed to show efficacy in a phas
Ipsen has suffered rather a setback in its marathon effort to bring palovarotene to market for ultra rare disease fibrodysplasia ossificans progressiva (FOP), after EU advisors recommended
Amicus Therapeutics could be just weeks away from getting EU approval for its new Pompe disease therapy Pombiliti after getting a positive opinion on the drug from the EMA's human medicines
AstraZeneca's oncology portfolio continues to deliver, with a recommendation for EU approval of its new Imfinzi/Imjudo immunotherapy combination heading a flurry of regulatory updates.
CSL's gene therapy for haemophilia B has been recommended for approval by the EMA's human medicine committee, setting up a decision by the European Commission early next year.
Software that can be used to monitor patients with neurodegenerative disorder amyotrophic lateral sclerosis (ALS) using their voice patterns has been granted breakthrough