European Medicines Agency

European medicines regulatory network adopts EU common standard for electronic product information

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Sputnik V due to submit vaccine data to WHO this month

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EU regulator starts real-time review of Merck’s COVID-19 pill

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Sacituzumab Govitecan receives positive CHMP opinion as 2L treatment for adult patients with metastatic triple-negative breast cancer

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EMA studying data on Pfizer’s COVID-19 vaccine booster dose

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European Medicines Agency (EMA) grants Orphan Designation for AOC 1001

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EMA validates Bristol Myers Squibb’s two Opdivo-based applications to treat cell carcinoma

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FDA accepts application for Roche’s Faricimab 

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EMA grants Orphan Drug Designation to Saroglitazar Mg for treating patients with PBC

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EU begins real-time review of Sanofi-GSK COVID-19 vaccine

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