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March 04, 2021
The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.
March 02, 2021
The UK government is taking advantage of the new regulatory flexibility, afforded by Brexit, to boost the country’s competitiveness in pharma.
February 17, 2021
The European Medicines Agency announced it has started a review of drugs that contain amfepramone due to concerns that include heart problems and high blood pressure in the lungs.
The EC has granted marketing authorization to Celltrion Healthcare for its adalimumab biosimilar, Yuflyma (CT-P17).
February 11, 2021
EMA has clarified its position on the European approval process of the Sputnik V vaccine.
February 10, 2021
The agency is developing guidance to help manufacturers make changes to existing COVID-19 vaccines to treat new variants in the coronavirus.
February 02, 2021
The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.
January 29, 2021
The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.
The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).
January 07, 2021
EMA has chosen Panalgo's Instant Health Data (IHD) platform to enable rapid analyses of real-world data.