USA – Pfizer: le spray nasal anti-migraine approuvé par la FDA

Pfizer a annoncé vendredi que la Food and Drug Administration (FDA) américaine avait approuvé le Zavzpret, son spray nasal pour le traitement de la...

International – Covid-19 nasal vaccine is here: Price, benefits, all you need to know

Vaccine maker Bharat Biotech's intranasal vaccine for Covid-19, the first in the world, is set to be launched soon and is already available on...

International – Un médicament fait espérer l’éradication de la maladie du sommeil

L’éradication de la « maladie du sommeil » – ou trypanosomiase africaine – serait-elle à portée de main ? C’est l’espoir que suscitent les résultats d’un essai...

USA – FDA amends COVID vaccine EUAs, considers animal studies to accelerate updates

Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and...

Europe – EMA recommends revocation of authorisation for sickle cell disease medicine Adakveo

EMA’s human medicines committee (CHMP) has recommended revoking the marketing authorisation for Adakveo (crizanlizumab), a medicine for preventing painful crises (called vaso-occlusive crises) in patients aged...

Latin America – Brazil, Mexico launch efforts to ease biosimilar regulation

In recent weeks, both Brazilian and Mexican regulatory authorities have made public their eagerness to spur domestic production – and faster regulation – of...

UK – NICE sees ‘promise’ in four UTI tests that could help in fight...

AMR develops when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time, making them more resistant to drug treatments. As a...
Modalités de dépôt d'un dossier de demande d'évaluation d'acte professionnel

France – Covid-19 : la HAS précise le cadre d’utilisation de Xevudy®

Plusieurs traitements sont actuellement disponibles pour lutter contre le virus de la Covid-19. C’est le cas de Xevudy® , anticorps monoclonal à double action : il neutralise...

International – Moderna announces trial results for new COVID-19 booster vaccine candidate

The analysis shows that the new vaccine offers better protection against Omicron than Moderna’s original vaccine, Spikevax, producing nearly double the neutralising antibody levels. The...

Europe – Guidance on the anonymisation of protected personal data and assessment of commercially...

This document aims at giving general guidance to companies on the retention/removal of Protected Personal Data (PPD) and identification of Commercially Confidential Information (CCI)....