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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,
Bavarian says mpox vaccine approved by EU regulator for adolescents
Bavarian Nordic said on Thursday its mpox vaccine was approved by the EU's drug regulator for use in adolescents, bolstering the case for using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa.
Bavarian Nordic mpox shot gains approval for adolescents in EU
The European Commission has approved Bavarian Nordic's (OTCPK:BVNRY)(OTCPK:BVNKF) mpox shot for adolescents between 12 and 17 years old. Approval was based on data from a clinical study of more than 300 adolescents and 200 adults that found non-inferior immune responses and similar safety profile between both age groups after two standard doses
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 ...
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 ...
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 ...
1d
Press Release: Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old
Dupixent recommended for EU approval by the CHMP to treat eosinophilic esophagitis in children as young as 1 year old Recommendation based on a ...
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 ...
The New York Times
4d
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 ...
devdiscourse
41m
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
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 ...
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 ...
9h
Maintaining Buy Rating on Apellis Pharmaceuticals Amid European Setback and US Market Focus
Bank of America Securities analyst Tazeen Ahmad has maintained their bullish stance on APLS stock, giving a Buy rating yesterday. Tazeen Ahmad ...
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