The European Medicines Agency (EMA), in collaboration with the European Commission (EC), has established a standard procedure for manufacturers of certain high-risk medical devices to request ...

The efficiency of the approval process ... are successful, the EMA plans to extend systematic monitoring into 2025 to maintain improvements. The 5th Medical Device Software Development Summit ...

The European Medicines Agency (EMA) said Monday it has established a way for manufacturers of certain high-risk medical devices to request scientific advice. Manufacturers of class III devices and ...

Femasys (FEMY) announces Conformite Europeene mark certification under European Union Medical Device Regulation as the first regulatory ...

A false claim is circulating online that the European Medicines Agency (EMA) has acknowledged that mRNA vaccines have not ...

AstraZeneca’s Imfinzi (durvalumab) in combination with chemotherapy has been recommended for approval in the European Union (EU ... of the European Medicines Agency (EMA) based its positive opinion on ...

if approved, could help transform efforts to end the HIV epidemic globally,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. The EMA applications are supported by data from ...

The Montreal-based C3i Center obtained regulatory approval from the European Medicine Agency (EMA) to produce cell therapy therapies for the European market. The company obtained a certificate of ...

Approval from EMA to expand the Phase III trial FLAMINGO-01 into Europe enhances the company's research capabilities and potential market reach. The activation of approximately 110-115 clinical ...