Researchers at the LKS Faculty of Medicine of the University of Hong Kong (HKUMed) have invented an oral formulation of ...

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

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars:  On January 30, 2025, the European Medicines Agency (EMA) Committee ...

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 ...

Valneva (VALN) announced that the Medicines and Healthcare products Regulatory Agency or MHRA has granted marketing authorization in the United ...

The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...

Ocugen (OCGN) announced that the European Commission has provided a positive opinion from the EMA’s, or European Medicines Agency’s, Committee ...

The ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.

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

Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...

AMSTERDAM, Jan 27 (Reuters) - The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social ...