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EU nod for Novo's diabetes drug Rybelsus pharmatimes
April 07, 2020
Novo Nordisk's Rybelsus (oral semaglutide) has won European approval for type II diabetes, offering adults a new treatment option as the first and only oral glucagon-like-peptide-1 (GLP-1) receptor agonist.
EU addresses potential impact of COVID-19 on medicines supply expresspharma
March 12, 2020
The mandate is to provide strategic leadership for urgent and coordinated action within the EU in case a crisis caused by major events.
EU Marketing Authorisation change for Maviret pharmatimes
March 10, 2020
The European Commission has granted AbbVie permission to change the Marketing Authorisation for Maviret (glecaprevir/pibrentasvir) to eight weeks of treatment.
Givlaari approved in EU following recent CHMP nudge pharmatimes
March 06, 2020
Alnylam has received approval from the European Commission for its second RNAi medicine - this time an acute hepatic porphyria (AHP) drug, Givlaari (givosiran).
EMA releases findings from pharmacovigilance report europeanpharmaceuticalreview
December 19, 2019
A new pharmacovigilance document from the European Medicines Agency shows that the medicine safety system in the EU is effective.
Germany imports largest ever shipment of EU medicinal cannabis europeanpharmaceuticalreview
September 16, 2019
An import of medicinal cannabis from Portugal to Germany signifies the largest quantity ever moved within the EU, highlighting a surge in the medicinal cannabis products market.
Sanofi and Regeneron get EU approval for Dupixent expresspharma
August 07, 2019
European Commission has extended marketing authorisation for Dupixent European Union to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis
EMA recommends Vitrakvi for EU marketing authorisation europeanpharmaceuticalreview
July 30, 2019
The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.
US and EU enter Mutual Recognition Agreement for drug manufacturing inspections europeanpharmaceuticalreview
July 17, 2019
The FDA and EMA have agreed to rely on each other’s assessment of pharmaceutical manufacturing sites to reduce duplicative work.
EU releases guidance for medicine shortages europeanpharmaceuticalreview
July 09, 2019
The EU has issued two guidance documents intended to advise the pharmaceutical industry and patients during medicinal shortages.

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