Europe – European Commission approves cystic fibrosis treatment for six to 11-year-olds
The European Commission (EC) has granted approval for the label extension of Kaftrio (ivacaftor/tezacaftor/elexacaftor), in a combination regimen with ivacaftor.
This has been recommended for...
Europe – Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation...
EMA continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which is now spreading...
USA – Manufacturers object to provisions in FDA’s microbiological quality guidance
An industry trade group and pharmaceutical manufacturers are calling for revisions to the US Food and Drug Administration’s (FDA) draft guidance on microbiological quality...
Europe – EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir)...
EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA...
UK – The NICE recommends Rinvoq for psoriatic arthritis patients
The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending Rinvoq (upadacitinib) 15mg as a new option...
Europe – Revised Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated...
The European Pharmacopoeia (Ph. Eur.) is seeking stakeholder feedback on the revised general chapters Colony-forming cell assay for human haematopoietic progenitor cells (2.7.28) and Nucleated cell count and...
USA – FDA’s drug volume reporting requirements face pushback
As the FDA is looking to reduce drug shortages further by collecting more data on the volume of drugs and APIs manufactured worldwide, companies...
USA – FDA approved more first-in-class drugs, gave more accelerated approvals in 2021
The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure...
France – Covid-19 : accès précoce accordé au Xevudy® en traitement curatif
En complément de la campagne de vaccination, et notamment la campagne de rappel, et du renforcement des gestes barrières et des mesures de distanciation...
UK – NICE recommends MSD’s Keytruda in combination with chemotherapy for routine treatment of...
The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending MSD’s (known as Merck in the US...
