Archive

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 […]

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) […]

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 […]

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 […]

EU experts back second COVID-19 booster for vulnerable groups

Written by | 2 Aug 2022

The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) have recommended second booster doses of mRNA COVID-19 vaccines for people aged 60 […]

Smallpox vaccine approved for monkeypox prevention

Written by | 1 Aug 2022

The European Medicines Agency (EMA) has recommended extending the use of Imvanex, a smallpox vaccine, for the prevention of monkeypox infection in adults. The news came as the […]

Global drug regulators to embrace real-world evidence

Written by | 31 Jul 2022

The European Medicines Agency (EMA) has backed a joint statement by global regulators calling for greater collaboration on the use of real-world evidence in regulatory decision-making. The potential […]

EMA gets a budget boost

Written by | 14 Jan 2022

The EU drug regulator, the European Medicines Agency (EMA), has a beefed-up budget for 2022 and plans to grow further in the years ahead. The watchdog’s Management Board […]

EU backs new COVID-19 treatments

Written by | 13 Jan 2022

The European Medicines Agency (EMA) has authorised several new therapies and vaccines for COVID-19 which offer fresh hope of containing the two-year old pandemic, the EU drug watchdog […]

New EU guidance on registry-based studies

Written by | 13 Nov 2021

The European Medicines Agency (EMA) has published new guidance on generating evidence from patient registries. The publication aims to increase the quality of research using the wealth of […]

EU drug watchdog backs ‘medicines repurposing’ pilot

Written by | 11 Nov 2021

Medicines approved by the European Medicines Agency (EMA) to treat one illness could be repurposed by academics and non-governmental organisations as therapies for other illnesses, as part of […]

Countdown to launch of Europe’s new clinical trials system

Written by | 7 Sep 2021

The clock is ticking down to the ‘go-live’ date for the EU’s new Clinical Trials Information System (CTIS) which will roll out on 31 January 2022. The European […]

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