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EMA recommends authorisation for remdesivir to combat COVID-19
The EMA's human medicines committee (CHMP) has recommended a conditional marketing authorisation for Veklury (remdesivir) to treat COVID-19.
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EMA human medicines committee (CHMP)
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EMA to fast-track development of COVID-19 vaccines and therapeutics
The EMA has announced new regulatory changes that will help potential COVID-19 vaccines and therapeutics accelerate through development.
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EMA initiates ‘rolling review’ of remdesivir, potential COVID-19 treatment
The EMA's human medicines committee has announced it has begun a rolling review of remdesivir for the treatment of COVID-19, to examine its safety and effectiveness.
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EMA recommends eight drugs for approval from April meeting
The EMA's human medicines committee has adopted a positive opinion for eight medicines, recommending their marketing authorisation.
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Committee for Medicinal Products for Human Use (CHMP) meeting highlights
A summary of the CHMP meeting conclusions, including medicines recommended for approval and indication extension and several safety review findings.
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“Harmonised approach” promoted for COVID-19 treatment clinical trials
The EMA has urged that the research community prioritise large randomised controlled studies for COVID-19 treatments and vaccines.
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EMA releases results from February meeting, recommending two medicines
The EMA has recommended granting marketing authorisation to two medicines and extending the indications for three more following its latest meeting.
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EMA announces medicine approval recommendations from November meeting
The EMA CHMP has revealed its suggestion to grant marketing authorisation to seven medicines after its most recent meeting.
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Seven medicines recommended for approval by EMA
The EMA CHMP has given a positive opinion for marketing authorisation approval to seven medicines following its October meeting.