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Highlights of the EMA’s human medicine committee meeting, April 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
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EMA's Committee for Medicinal Products for Human Use (CHMP)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-300x278.jpg)
![sign of the European Medicines Agency building in Amsterdam [Credit: martinbertrand.fr/Shutterstock.com].](https://www.europeanpharmaceuticalreview.com/wp-content/uploads/EMA-1-e1617017465349.jpg)
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European Medicines Agency’s CHMP meeting highlights March 2021
In its March meeting the EMA’s human medicines committee recommended five medicines for approval and concluded its review of regdanvimab as a treatment for COVID-19.
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EMA approves increased manufacturing capacity for COVID-19 vaccines
The approval of at least one new manufacturing site based in Europe for each of the approved COVID-19 vaccines should increase supply for the EU.
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Janssen COVID-19 Vaccine authorised for use in EU
After a positive recommendation from the EMA, the European Commission has granted the single-dose vaccine conditional marketing authorisation.
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Bamlanivimab and etesevimab prevent COVID-19 related deaths
In a high-risk patient cohort, treatment with the combination of bamlanivimab and etesevimab reduces COVID-19 related hospitalisation and death by 87 percent.
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EMA concludes review of Lilly’s COVID-19 antibody therapies
The human medicines committee decided that there was significant evidence to endorse the use of a combination of bamlanivimab and etesevimab in outpatients at high risk of severe COVID-19.
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EMA begins rolling review of Sputnik V COVID-19 vaccine
The EU regulator has begun reviewing preclinical and early trial data for Sputnik V, the COVID-19 vaccine developed by Russia.
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EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
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EMA issues its requirements for adapting COVID-19 vaccines for viral variants
The European Medicines Agency has set out its guidelines for vaccine manufacturers adapting their approved COVID-19 vaccines to combat viral variants.
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EMA COVID-19 treatment evaluations update
The EMA has begun a rolling review of Celltrion’s regdanvimab (CT-P59) antibody for COVID-19 and assessing new data on Veklury (remdesivir).
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EMA’s transformative treatments of 2020
In this article, we summarise the trial findings for the European Medicines Agency’s 13 most transformative therapies of 2020.
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EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
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EC approves first high concentration, low-volume adalimumab biosimilar
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
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February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
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EMA initiates rolling review of Regeneron’s COVID-19 mAb
The EMA's CHMP has begun a rolling review of REGN-COV2, Regeneron's COVID-19 antibody candidate, after successful pre-clinical trials.
