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Green light for four new medicines in the EU

Written by | 9 Mar 2025

The European Medicines Agency (EMA) has recommended four new products for approval, and extended the use of sixteen other drugs. The decisions, which brings to 12 the total… read more.

EU launches new map of clinical trials

Written by | 8 Mar 2025

A new clinical trial map has been developed and published as part of the Accelerating Clinical Trials in the European Union (ACT EU) initiative. The map is accessible… read more.

EU drug watchdog warns of scams using regulator’s logo

Written by | 8 Mar 2025

The European Medicines Agency (EMA), the EU’s drug regulator, is warning the public and companies to beware of fraud. The agency has been alerted to several scams and… read more.

Shingrix new prefilled syringe presentation accepted for review by European Medicines Agency – GSK

Written by | 1 Feb 2025

GSK plc announced that the EMA has accepted for review the regulatory application of a prefilled syringe presentation of Shingrix (GSK’s Recombinant Zoster Vaccine or RZV) for the… read more.

EMA approves 17 medicines at December meeting

Written by | 28 Dec 2024

The European Medicines Agency rounded off a busy year by approving seventeen new medicines. At its December meeting, the Committee for Medicinal Products for Human Use (CHMP) also… read more.

EU drug regulators agree common approach to data transparency

Written by | 27 Dec 2024

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a comprehensive overhaul of their guidance on the identification of commercially confidential information (CCI) and… read more.

EU approved 114 medicines in 2024

Written by | 26 Dec 2024

The European Medicines Agency has approved more than 100 new medicines for the first time in fifteen years. Of the 114 medicines given the green light in 2024,… read more.

EU drug watchdog rewrites conflict of interest rules

Written by | 4 Nov 2024

The European Medicines Agency (EMA) is revising its ‘competing interests’ policy for experts and members of scientific committees. The new rules are expected to be adopted by the… read more.

EU aims to make medicines review more efficient

Written by | 3 Nov 2024

The European Medicines Agency (EMA) and the European medicines regulatory network plan to improve the efficiency of how new medicines are assessed and approved. A new initiative aims… read more.

Green light for 10 new medicines in the EU

Written by | 2 Nov 2024

Ten new medicines have been recommended for approval by the European Medicines Agency (EMA), with another six products recommended for extension of their therapeutic indications. This brings to… read more.

Eylea 8 mg pre-filled syringe approved in the EU – Bayer

Written by | 14 Sep 2024

The European Medicines Agency (EMA) has approved the pre-filled syringe for the administration of Eylea™ 8 mg (114.3 mg/ml solution for injection) in the European Union. The new… read more.

The European Ccommission approves Avzivi, a biosimilar referencing bevacizumab – Bio Thera Solutions

Written by | 9 Sep 2024

The European Medicines Agency (EMA) has approved Avzivi (BAT 1706), a biosimilar referencing bevacizumab (Avastin), according to an announcement from Bio-Thera Solutions. Avzivi is intended for the treatment… read more.

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