While the FDA, European Medicines Agency (EMA), and the UK’s Medicines ... as specified in the recent EU pharmacovigilance legislation. Examining the findings of the MHRA’s most recent ...

GSK on Monday said that the European Medicines Agency has agreed to review a request to approve the British drugmaker's ...

FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the European Medicines Agency (EMA) has validated for parallel accelerated review the company’s ...

This would see the UK mirroring decisions made by the European Medicines Agency, while also laying ... and investigational medicinal products, pharmacovigilance procedures and new IT systems.

The European Union drug regulator found no evidence that a class of diabetes and weight-loss drugs, such as Novo Nordisk's hugely popular Wegovy, are linked to suicidal thoughts, it said on Friday ...

The EU executive included a new 'Buy Europe' mechanism with its long-awaited proposal for a Critical Medicines Act, unveiled on Tuesday, a key piece of health legislation for this term. The ...

The regulator's Pharmacovigilance Risk Assessment ... The finding comes after the European Medicines Agency extended in December its review into the class of weight-loss and diabetes drugs known ...