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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.

EU gives green light for 7 new medicines

Written by | 23 Oct 2023

The European Medicines Agency (EMA) has recommended seven medicines for approval at its October 2023 meeting. The brings the total number of newly approved medicines this year to… read more.

New transparency rules for EU Clinical Trials System

Written by | 22 Oct 2023

The European Medicines Agency (EMA) has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The changes give access… read more.

EU drug watchdog warns of fake Ozempic pens

Written by | 22 Oct 2023

The European Medicines Agency (EMA) is warning patients and healthcare professionals to beware of pre-filled pens falsely labelled as Ozempic, a diabetes medicine linked to weight loss. National… read more.

First RSV vaccine to protect infants and older adults

Written by | 7 Sep 2023

EU medicines regulators have approved a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation… read more.

EMA to revamp Emergency Task Force

Written by | 22 Jun 2023

The European Medicines Agency (EMA) was praised for its contribution to the EU’s pandemic response, as the agency took steps to review the role of its Emergency Task… read more.

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