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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… read more.

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… read more.

CHMP recommends Opdivo for the adjuvant treatment of adults with muscle-invasive urothelial carcinoma – BMS

Written by | 6 Jul 2022

Bristol Myers Squibb announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo (nivolumab) for the… read more.

EU gives green light for four new medicines

Written by | 1 May 2022

The European Medicine Agency’s key expert body – the Committee for Medicinal Products for Human Use (CHMP) – has recommended that four medicines be approved in the EU…. read more.

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… read more.

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… read more.

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… read more.

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… read more.

EMA gives green light for six new medicines

Written by | 10 Nov 2021

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory… read more.

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… read more.

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… read more.

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… read more.

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