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February 28, 2022
EMA has recommended granting a marketing authorization in the EU for Kimmtrak (tebentafusp), a new medicine for a rare type of eye cancer.
EMA has recommended approval of Spikevax for children aged 6 to 11.
Pfizer and BioNTech receive positive opinion for COVID-19 vaccine booster in adolescents 12 through 17 years of age in the EU.
February 25, 2022
FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.
February 24, 2022
FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics.
Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.
February 23, 2022
Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.
MHRA has opened a consultation on the proposed changes to clinical trial legislation in the UK.
Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.
February 22, 2022
The European Medicines Regulatory Network has adopted a Common Standard for the electronic product information on medicines in the European Union.