UK – NICE recommends Roche’s faricimab (Vabysmo) as a treatment option for two leading...

The National Institute for Health and Care Excellence (NICE) has recommended Roche’s faricimab (Vabysmo) as a treatment option for two leading forms of sight...

Europe – Hydroxyethyl-starch solutions for infusion recommended for suspension from the market

Update as of 25 May 2022: On 24 May 2022, the European Commission issued a legal decision confirming the suspension of the marketing authorisations of HES solutions for infusion. If...

Europe – Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for...

The assessment report of the CHMP’s Article 5(3) of Regulation (EC) No 726/2004 opinion on nitrosamine impurities in human medicinal products provides general guidance...

UK – NICE recommends Sanofi and Regeneron’s Libtayo for advanced CSCC

The treatment recommendation is specifically for eligible adults for whom surgery or radiation treatment is not appropriate. NICE’s decision means eligible patients will be...

Europe – EMA medical terms simplifier

This compilation gives plain-language descriptions of medical terms commonly used in information about medicines. Communication specialists at EMA use these descriptions for materials prepared...

International – Pfizer/BioNTech vaccine effective against Omicron in children five and under

According to recent clinical trial results from Pfizer and BioNTech, a third COVID-19 vaccine dose was well tolerated by children aged five and below,...

Europe – Addendum to the guideline on the evaluation of medicinal products indicated for...

This addendum to the Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 rev 3) has been developed to...

Europe – Guideline on the evaluation of medicinal products indicated for treatment of bacterial...

This Guideline merges, revises and adds to the guidance previously included in the Guideline on the evaluation of medicinal products indicated for treatment of...

Europe – EMA guidance supports development of new antibiotics

As part of its efforts to support a global approach to the development of new antimicrobial medicines, EMA has published the final revised guideline on the...

UK – G7 health ministers unite to protect world from another pandemic

Commitments also made on tackling antimicrobial resistance (AMR) – a global killer costing millions of lives a year Focus on climate and health...

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