Ten medicines have been recommended for marketing authorisation and 10 extensions of indication have been suggested by the EMA.
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EMA's Committee for Medicinal Products for Human Use (CHMP)
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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…
The EMA has begun to review dexamethasone to provide an opinion on the results of the RECOVERY study for the treatment of adults admitted to hospital with COVID-19.
Dapivirine Vaginal Ring (dapivirine) and Blenrep (belantamab mafodotin) have been recommended for approval by the EMA's CHMP, along with nine other medicines.
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.
The European Medicines Agency (EMA) said its assessment of the conditional marketing authorisation (CMA) application will be performed under a reduced timeframe, with a decision potentially delivered in weeks.
The COVID-19 EMA pandemic Task Force (COVID-ETF) will aid in the development, authorisation and safety monitoring of COVID-19 vaccines and therapeutics.