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EMA committee recommends 13 medicines for approval in January meeting
The committee for human medicinal products recommended AstraZeneca’s COVID-19 vaccine be granted conditional marketing authorisation alongside 12 other approvals.
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EMA's Committee for Medicinal Products for Human Use (CHMP)
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EMA receives authorisation application for AstraZeneca COVID-19 vaccine
The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
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European Commission approves Moderna’s COVID-19 vaccine
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
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EC orders additional 80 million doses of Moderna’s COVID-19 vaccine
Europe will receive an extra 80 million doses of Moderna's mRNA-1273, a COVID-19 vaccine candidate, following the EC's decision.
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EMA recommends 15 medicines for approval following December meeting
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
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EMA begins rolling review of Janssen’s COVID-19 vaccine candidate
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson's COVID-19 vaccine.
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EMA initiates rolling review of Moderna’s COVID-19 vaccine
The rolling review will shorten the approval timeframe by evaluating data on the safety, efficacy and quality of the mRNA-1273 vaccine as it becomes available.
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CHMP recommends five medicines for approval in latest meeting
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
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AstraZeneca’s Forxiga approved in EU to treat chronic heart failure
The European Commission has approved Forxiga (dapagliflozin) for use in the EU to treat symptomatic chronic heart failure with reduced ejection fraction.
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EMA recommends 10 medicines for approval in October meeting
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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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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EMA begins rolling review of AstraZeneca COVID-19 vaccine
The EMA's human medicines committee has initiated a rolling review of AstraZeneca's COVID-19 vaccine candidate to test its efficacy.
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EMA recommends seven medicines for approval after September meeting
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
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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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Dexamethasone Taw application to treat COVID-19 to be evaluated by EMA
Dexamethasone Taw will be examined by the EMA on an accelerated assessment timetable, to assess whether it should be given to patients with COVID-19.
