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EMA recommends first COVID-19 vaccine for children aged 12 to 15 europeanpharmaceuticalreview
June 03, 2021
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
EU’s Medical Device Regulation is now applicable europeanpharmaceuticalreview
May 28, 2021
Europe’s Medical Device Regulation is now applicable to medicines with an integral device, devices containing an ancillary medicinal substance and several other products.
GSK-Vir’s Covid-19 drug sotrovimab obtains positive EMA opinion pharmaceutical-technology
May 25, 2021
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) has issued a positive scientific opinion for GlaxoSmithKline (GSK) and Vir Biotechnology’s sotrovimab (VIR-7831) as early Covid-19 treatment.
EMA, MHRA to review Vertex' Kaftrio for children with CF pharmatimes
May 21, 2021
The European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have validated Vertex' applications to expand the scope of its cystic fibrosis (CF) treatment Kaftrio (ivacaftor/tezacaftor/elexacaftor).
EMA to assess if Olumiant should be authorised for hospitalised COVID-19 patients europeanpharmaceuticalreview
May 06, 2021
The EMA will conduct an accelerated assessment and issue its decision on whether Olumiant (baricitinib) can be used in hospitalised COVID-19 patients by July.
Tagrisso moves closer towards EU approval for early-stage lung cancer pharmatimes
April 29, 2021
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s (AZ) Tagrisso for approval in the EU for the treatment of early-stage lung cancer patients.
EMA PRIME status granted for Vertex, CRISPR Therapeutics’ gene therapy CTX001 pharmatimes
April 29, 2021
Vertex Pharmaceuticals and CRISPR Therapeutics’ gene therapy CTX001 has been granted a Priority Medicines (PRIME) designation from the European Medicines Agency (EMA).
EMA and ECDC to collaborate on post-marketing monitoring of COVID-19 vaccines europeanpharmaceuticalreview
April 28, 2021
Under a new initiative, the EMA will monitor on the safety of marketed COVID-19 vaccines while the ECDC monitors their effectiveness in Europe.
Highlights of the EMA’s human medicine committee meeting, April 2021 europeanpharmaceuticalreview
April 27, 2021
The Committee for Medicinal Products for Human Use (CHMP) recommended eight drugs for approval and nine indication extensions.
EMA board confirms the EU clinical trial portal and database is fit for purpose europeanpharmaceuticalreview
April 26, 2021
The adoption of the 2014 Clinical Trial Regulation moves one step closer as the EMA confirms a key aspect, the EU trials database and portal, is on track for implementation.

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