The EMA anticipates that the ability to access scientific advice will foster innovation among medical device manufacturers.

Granted IMC-G.A.P. Equivalency Certification by Control Union (“CU”)Milestone to export to Israel and EU-GMP facilities in Europe and ...

Data on mRNA vaccines sent by Moderna to European regulators before the COVID-19 outbreak included early tests of the mRNA ...

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European ...

Immunotherapy has shown a 27% reduction in mortality for patients with limited-stage small cell lung cancer, based on Phase ...

The EUR 0.75 co-payment for every prescription in place as of the 1st of January 2025 is not a good solution, says Vice-Dean ...

AstraZeneca (AZN.L, AZN) announced Imfinzi was recommended for approval in the European Union by CHMP as first and only immunotherapy ...

The trip is part of what the PM calls a "reset" between the UK and the European Union. Kaja Kallas says Europe needs to increase investment to keep pace with threats facing the continent.

The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive ...

Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...

RAHWAY, N.J. - Merck & Co ., Inc. (NYSE:MRK) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its pneumococcal ...