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EMA begins rolling review of BNT162b2 COVID-19 vaccine
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
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European Commission (EC)
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UN pledged almost $1 billion for efforts to combat COVID-19
The WHO has said that the Access to COVID-19 Tools Accelerator will receive almost $1 billion of funding to boost access to tests, treatments and vaccines.
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EU to receive 300 million COVID-19 vaccine doses from Sanofi and GSK
A contract for 300 doses of the investigational COVID-19 vaccine candidate has been signed by the European Commission (EC).
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Imfinzi approved in EU to treat extensive-stage small cell lung cancer
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
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Pfizer and BioNTech may supply EU with 200 million doses of COVID-19 vaccine
The companies and European Commission will soon enter contract negotiations for the supply of their investigational COVID-19 vaccine candidate BNT162b2.
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Blenrep granted CMA for relapsed or refractory multiple myeloma
The European Commission granted the conditional marketing authorisation (CMA) based on data from a trial in which Blenrep achieved an overall response rate of 32 percent.
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Vertex’s Kaftrio approved for use in Europe and made accessible on the NHS
The European Commission and European Medicines Agency have approved the triple combination Kaftrio for use in certain cystic fibrosis patients, triggering the drug to be accessible on the UK’s National Health Service.
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AstraZeneca to supply Europe with up to 400 million doses of COVID-19 vaccine
An agreement between AstraZeneca and the European Commission means the company will supply up to 400 million doses of its AZD1222 COVID-19 vaccine.
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European Commission approves Novartis’ Xolair® (omalizumab)
Novartis' Xolair (omalizumab) has been approved by the European Commission as an add-on therapy with intranasal corticosteroids to treat severe chronic rhinosinusitis with nasal polyps.
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Sanofi and GSK to supply UK with 60 million doses of COVID-19 vaccine
Sanofi and GSK have reached an agreement with the UK government to supply up to 60 million doses of their COVID-19 vaccine.
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EC approves subcutaneous formulation of Remsima®
The European Commission has granted marketing authorisation to Celltrion's Remsima (infliximab, CT-P13) subcutaneous formulation.
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CureVac recieves €75 million loan for vaccine development and manufacturing expansion
The European Investment Bank (EIB) will provide three €25 million instalments to support CureVac’s vaccine development and expansion to mRNA production facilities.
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EMA recommends Idefirix (imlinfidase) is granted marketing authorisation
The European Medicines Agency (EMA) recommended Idefirix is granted conditional marketing authorisation for highly sensitised patients awaiting kidney transplant.
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CHMP recommends cystic fibrosis treatment Kaftrio is granted marketing authorisation
The European Medicines Agency's human medicines committee (CHMP) said the treatment would offer a therapeutic option for certain cystic fibrosis phenotypes that are currently untreatable.
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Further billions pledged to ensure equitable access to COVID-19 treatments
The European Investment Bank (EIB), in partnership with the European Commission (EC), have pledged an additional €4.9 billion for use in the global coronavirus response funds.
