WILMINGTON, DE — The European Commission has approved Zynyz (retifanlimab), developed by Incyte (Nasdaq: INCY), in ...

The European Medicines Agency (EMA) announced Friday it has recommended Moderna’s combined mRNA COVID-19 and flu vaccine be granted market authorization in the European Union, marking the first time ...

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for Moderna’s vaccine in the U.S.

Acadia Pharmaceuticals isn’t taking its recent rejection from the European Medicines Agency lying down, vowing to seek a ...

COMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive C ...

MAA submission to the European Medicines Agency represents a key regulatory milestone in LENZ’s strategy to expand global access to VIZZ Submission of MAA in Europe results in the fifth ex-U.S.

The European Medicines Agency (EMA) has released draft guidance for sponsors conducting clinical trials during public health ...

The European Medicines Agency (EMA) has officially qualified PolTREG to submit an application for marketing authorization in the European Union for the PolTREG-T1D cell preparation. GDAŃSK, Poland, ...

Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced that it has received notification from its licensing partner, Accord Healthcare, that the European Medicines Agency's (EMA) Committee for ...

WALTHAM, Mass.--(BUSINESS WIRE)--Affinia Therapeutics (“Affinia”), an innovative gene therapy company with a pipeline of first-in-class and/or best-in-class adeno-associated virus (AAV) gene therapies ...

*As director general of the British Specialist Nutrition Association (BSNA), Declan O’Brien had a unique overview of one of the fastest-growing areas within medical therapy – intravenous foods and ...