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EU’s Clinical Trials Regulation comes into full force
The ruling requires all trials across the EU to be filed through the European Medicines Agency’s digital filing system.
Medscape16h
EMA to Review New Safety Data on Alzheimer’s Drug Leqembi
The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.
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EMA recommends Bavarian Nordic’s chikungunya vaccine for adults and teenagers
If authorised, Vimkunya would be the first vaccine in the EU to protect adolescents aged 12 to 17 against Chikungunya.
FiercePharma17h
Merck vaccine, Daiichi ADC win approval recommendations in busy week at EU's drug regulator
Several medicines are poised to reach new heights after winning key endorsements from European drug regulators. | Among those ...
EU medicines agency quits X, moves to Bluesky
The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming ...
Medscape17h
EMA Expedites Adolescent Chikungunya Vaccine Recommendation
Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...
Merck Gets Key European Regulatory Backing for Capvaxive Vaccine
Merck on Friday said the recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use covers the 21-valent conjugate vaccine for immunization for the prevention ...
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Biogen, Eisai Alzheimer’s drug review delayed in EU
Biogen (BIIB) stock in focus as company and partner Eisai (ESALF) face delay in the EU launch of Alzheimer's drug lecanemab.