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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.

Green light for two new medicines in the EU

Written by | 22 Jun 2023

The European Medicines Agency (EMA) has approved two new medicines at its May meeting. This brings to 30, the number of products given the green light by the… read more.

Green light for new medicines in the EU

Written by | 13 Apr 2023

The European Medicines Agency (EMA) approved a total of 89 new medicines in 2022. Of these, 41 had a new active substance which had never been authorised in… read more.

EMA trials scientific advice for high-risk medical devices

Written by | 11 Apr 2023

The European Medicines Agency (EMA) has launched a pilot to give scientific advice on the intended clinical development of certain high-risk medical devices. The new initiative applies to all… read more.

Study finds “important shortcomings” in official cancer drug information

Written by | 10 Apr 2023

Important information about cancer drug benefits, and related uncertainties, is frequently omitted from official prescription drug information sources for clinicians and patients in Europe, finds an analysis published… read more.

EU gives drug watchdog new ‘crisis management’ powers

Written by | 4 Feb 2023

The European Medicines Agency (EMA) has been given a new role in tackling shortages of critical medical devices during public health emergencies. From February 2023, the agency, which… read more.

Four new medicines approved by EMA

Written by | 4 Feb 2023

The European Medicines Agency (EMA) has approved four new medicines at its January meeting, getting 2023 off to a low-key start. The Agency’s key human medicines committee (CHMP)… read more.

EMA sets up expert group on medicine innovation

Written by | 27 Nov 2022

The European Medicines Agency (EMA) has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the… read more.

European Medicines Agency steps up effort on superbugs

Written by | 26 Nov 2022

The number of people in Europe dying because of antimicrobial resistant (AMR) infections has hit an all time high, according to new EU data. An estimated 35,000 Europeans… read more.

EMA offers enhanced support to non-profit drug developers

Written by | 10 Oct 2022

The European Medicines Agency (EMA) has launched a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in… read more.

EU green light for 12 new medicines – including 5 orphan drugs

Written by | 8 Oct 2022

The European Medicines Agency (EMA) has approved 12 new medicines at the September meeting of its key decision-making panel, the Committee on Human Medicinal Products (CHMP). The expert… read more.

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