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EU extends authorization of mpox vaccine to adolescents
EMA approves Bavarian Nordic’s mpox vaccine for teenagers
The European Medicines Agency (EMA) has approved the use of Bavarian Nordic’s mpox vaccine in adolescents, increasing the chances for its use in this age group in Africa. The label extension is via a type II variation – a route used when a major change is needed in the marketing authorisation for a medicine approved in Europe.
EU extends authorization of the mpox vaccine to adolescents
The European Commission on Friday extended the authorization of the Imvanex mpox vaccine to teenagers aged 12 to 17. "Although the overall risk of being infected with mpox for the general EU population remains low,
EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents
EU drug regulator approves use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents: Copengagen, Denmark Saturday, September 21, 2024, 10:00 Hrs [IST] Bavarian Nordic A/S, a
2d
EU regulator backs use of Novo's Wegovy for obesity-related heart condition
The European Medicines Agency backed the use of Novo Nordisk's popular drug Wegovy to help ease heart failure in people with ...
devdiscourse
8h
Major Updates in Health: Drug Approvals, Legal Battles, and Health Innovations
Recent developments in health include EU approval of Novo's Wegovy for obesity-related heart conditions, the US FDA's nod for ...
Medscape
1d
Two New Drugs Approved for Age-Related Macular Degeneration
The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...
1d
European Drug Agency Supports Novo Nordisk's Blockbuster Weight-Loss Drug Wegovy For Obesity-Related Heart Failure
Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of Novo Nordisk A/S’ (NYSE ...
devdiscourse
1d
Health Headlines: Regulatory Approvals and Legal Battles
The latest health news covers the European Medicines Agency's approval of Novo Nordisk's Wegovy for heart conditions linked ...
The New York Times
5d
European Medicines Agency
The
European
Medicines
Agency
also said that extra doses of the Moderna and Pfizer-BioNTech vaccines could be given to people with underlying health conditions as early as 28 days after a second ...
Medscape
1d
Hympavzi Approved in Europe for Severe Hemophilia A and B
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) recommended the granting of ...
1d
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...
16h
on MSN
Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult pati…
HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...
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