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EMA initiates rolling review of Janssen’s Covid-19 vaccine candidate pharmaceutical-technology
December 03, 2020
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has initiated a rolling review of Janssen and Cilag International’s Covid-19 vaccine candidate, Ad26.COV2.S.
EMA receives application for conditional marketing authorisation of Moderna COVID-19 vaccine worldpharmanews
December 02, 2020
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L.
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 worldpharmanews
December 02, 2020
EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID‑19 mRNA vaccine developed by BioNTech and Pfizer.
EMA highlights link between hydroxychloroquine and psychiatric disorders europeanpharmaceuticalreview
December 01, 2020
The EMA recommends updating the product information for chloroquine and hydroxychloroquine after confirming a link between these medicines and psychiatric disorders.
EMA validates Merck’s application to review tepotinib for lung cancer pharmaceutical-technology
November 30, 2020
The European Medicines Agency (EMA) has validated Merck’s application for reviewing tepotinib as a treatment for adult patients with advanced non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition factor gene (MET) exon 14 ...
European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations prnasia
November 27, 2020
Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) ...
EU drugs watchdog expects first application for COVID-19 vaccine in days expresspharma
November 27, 2020
Europe’s drugs watchdog said on Thursday it expects to receive the first application for conditional marketing approval for a COVID-19 vaccine “in the coming days”, the latest step towards making a shot available outside the United States.
EMA releases safety monitoring plan for COVID-19 vaccines europeanpharmaceuticalreview
November 18, 2020
The EMA’s safety monitoring plan outlines how new information after authorisation of COVID-19 vaccines will be collected and reviewed.
EMA begins rolling review of Moderna’s COVID-19 vaccine candidate expresspharma
November 18, 2020
Moderna also announced a supply agreement with the UK government to supply mRNA-1273, if approved for use by MHRA.
Six new medicines leap towards EU approval pharmatimes
November 17, 2020
The EMA’s human medicines committee (CHMP) recommended six medicines for approval at its November 2020 meeting.

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