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European watchdog to support African drug regulator

Written by | 7 Sep 2024

The EU medicines regulator, the European Medicines Agency (EMA), has announced plans to support its counterparts in African countries – paving the way for the creation of a… read more.

New EU plan to boost orphan medical devices

Written by | 6 Sep 2024

The European Medicines Agency (EMA) has launched a pilot programme to support the development and assessment of orphan medical devices in the European Union (EU). The initiative offers… read more.

EU gives green light for 14 new medicines

Written by | 5 Sep 2024

The European Medicines Agency (EMA) has approved fourteen new medicines at a summer meeting, with a further eleven products recommended for extension of therapeutic indications. The Agency’s human… read more.

EU green light for 10 new medicines – extends the scope of 11 existing products

Written by | 8 Jul 2024

The European Medicines Agency (EMA) has recommended ten new products for approval at a bumper June meeting which also saw therapeutic extensions granted for eleven drugs. The watchdog’s… read more.

Flu vaccines to target three virus strains this autumn

Written by | 7 Jul 2024

Vaccine manufacturers have been tasked with producing vaccines that protect against three influenza viruses, as Europe gears up for another flu season. Companies are actively producing millions of… read more.

EU regulators seeks new partners for real-world data network

Written by | 10 Apr 2024

Real-world data looks set to play an increasingly important role in how medicines are assessed for safety and effectiveness in Europe. The Data Analysis and Real-World Interrogation Network… read more.

Green light for 12 new medicines from EU watchdog

Written by | 8 Apr 2024

The European Medicines Agency (EMA) has recommended the approval of twelve new products, following reviews by its key human medicines committee (CHMP). This brings to twenty-five the number… read more.

EU recommendations for seasonal flu vaccine composition

Written by | 7 Apr 2024

The winter flu season may be over in the northern hemisphere, but EU regulators are already looking ahead to the next outbreak in autumn 2024. Influenza viruses continuously… read more.

Improving access to early-stage lung cancer care in Europe

Written by | 8 Mar 2024

There are stark differences between European countries when it comes to both the reimbursement of, and access to, new treatments for patients with early-stage lung cancer. There are… read more.

European Medicines Agency validation for MAA of nirogacestat for the treatment of adults with desmoid tumors – Springworks Therapeutics

Written by | 6 Mar 2024

SpringWorks Therapeutics, Inc. announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of… read more.

EU approves first gene editing therapy

Written by | 12 Jan 2024

The European Medicines Agency, the EU drug watchdog, has approved the first medicine using CRISPR/Cas9, a novel gene-editing technology. Casgevy (exagamglogene autotemcel) is indicated for the treatment of… read more.

Regulators in Europe set out vision for AI in medicines data

Written by | 11 Jan 2024

Artificial intelligence (AI) will play a role in drug development, including the way in which medicines are regulated, according to European experts. The European Medicines Agency (EMA) and… read more.

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