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EMA approves 17 medicines at December meeting

Written by | 28 Dec 2024

The European Medicines Agency rounded off a busy year by approving seventeen new medicines. At its December meeting, the Committee for Medicinal Products for Human Use (CHMP) also… read more.

CHMP positive for Flucelvax vaccine to prevent influenza

Written by | 24 Oct 2024

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Flucelvax, intended for the prevention of influenza… read more.

EU gives green light for 14 new medicines

Written by | 5 Sep 2024

The European Medicines Agency (EMA) has approved fourteen new medicines at a summer meeting, with a further eleven products recommended for extension of therapeutic indications. The Agency’s human… read more.

EU green light for 10 new medicines – extends the scope of 11 existing products

Written by | 8 Jul 2024

The European Medicines Agency (EMA) has recommended ten new products for approval at a bumper June meeting which also saw therapeutic extensions granted for eleven drugs. The watchdog’s… read more.

CHMP positive recommendation to change the marketing authorisation for Rozlytrek (entrectinib) – Roche

Written by | 2 May 2024

On 25 April 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for… 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.

Green light for 77 new medicines in the EU in 2023

Written by | 11 Jan 2024

A total of seventy-seven new medicinal products were approved in Europe last year, seven of which were given the green light in December. At European level, the EMA’s… 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.

CHMP recommends Abrysvo the first RSV vaccine to protect infants up to 6 months of age and older adults – Pfizer

Written by | 31 Jul 2023

The CHMP has recommended granting a marketing authorization for Pfizer’s Abrysvo (bivalent, recombinant), a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is… read more.

CHMP recommends Lyfnua as a treatment for refractory or unexplained chronic cough – Merck Inc

Written by | 25 Jul 2023

Merck Inc., known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)… 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.

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.

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