Archive

EU gives green light for new medicines

Written by | 27 Nov 2022

The European Medicine Agency’s (EMA) key human medicines committee (CHMP) has recommended four medicines for approval at its November 2022 meeting. This brings to 84 the number of […]

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 […]

Boost for global access to diabetes treatments

Written by | 1 May 2022

Two established diabetes medicines have been given the green light for use outside the EU – even when stored at higher temperatures – under the EU Medicines for […]

EU experts cautious on fourth dose of COVID-19

Written by | 30 Apr 2022

It is ‘too early’ to consider using a fourth dose of mRNA COVID-19 vaccines in the general population, according to the European Medicines Agency (EMA) and the European […]

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 […]

EMA approved 91 products in 2021

Written by | 12 Jan 2022

Thirteen new medicines were given the green light at the December meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). This brings to […]

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 […]

EU green light for more than 50 new drugs in 2021

Written by | 6 Sep 2021

The European Medicines Agency (EMA), the EU’s drug regulator, has now approved a total of 52 new medicines for human use in the first seven months of the […]

EU approval boosts COVID vaccine manufacturing capacity

Written by | 5 Sep 2021

The European Medicines Agency (EMA) has approved additional manufacturing capacity for the Pfizer/BioNTech COVID-19 vaccine in France – increasing production by 51 million doses by the end of […]

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