The EMA has received a conditional marketing authorisation application for the Oxford-AstraZeneca COVID-19 vaccine.
List view / Grid view
EMA's Committee for Medicinal Products for Human Use (CHMP)
Filter the results
Moderna's COVID-19 vaccine has been approved in the EU with a conditional marketing authorisation by the European Commission.
Europe will receive an extra 80 million doses of Moderna's mRNA-1273, a COVID-19 vaccine candidate, following the EC's decision.
The EMA's human medicines committee has released its results for the December meeting, suggesting which therapies should receive marketing authorisation.
The European Medicines Agency's CHMP has started a rolling review of Ad26.COV2.S, Johnson & Johnson'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.
The European Medicines Agency committee reports its November findings, including five drugs recommended for marketing authorisation.
The European Commission has approved Forxiga (dapagliflozin) for use in the EU to treat symptomatic chronic heart failure with reduced ejection fraction.
Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
The rolling review of BNT162b2 will allow the committee for human medicines (CHMP) to reach a faster decision on a future marketing authorisation application.
The EMA's human medicines committee has initiated a rolling review of AstraZeneca's COVID-19 vaccine candidate to test its efficacy.
Following its latest meeting, the EMA's CHMP has suggested granting marketing authorisation to seven medicines and extending the indications of 15 others.
Imfinzi (durvalumab) has been approved by the European Commission as a first-line treatment for extensive-stage small cell lung cancer, with chemotherapy.
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.
Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…