UK – NICE recommends UCB’s Fintepla for Dravet syndrome
Fintepla is an oral solution developed to treat seizures associated with Dravet syndrome, a rare, lifelong form of epilepsy that begins in infancy. The...
UK – NICE approves Merck’s Keytruda for adult patients with rare triple negative breast...
Merck & Co – known as MSD outside the US and Canada – has received a recommendation from The National Institute for Health and...
USA – FDA officials reflect on quality maturity model, quality metrics
The US Food and Drug Administration (FDA) has received “positive” feedback from stakeholders that participated in its quality metric management maturity (QMM) programs, said...
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...
USA – Medtech groups want more time to implement FDA’s QMSR rule
Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international...
USA – FDA issues Q&A on importation of prescription drugs from Canada
The US Food and Drug Administration (FDA) has offered some clarity on the legal requirements for small entities to import prescription drugs from Canada.
In final...
France – Lyon: ouverture d’un centre spécialisé dans la prise en charge des addictions...
Enrayer la spirale infernale de l’addiction, tel est l'objectif du nouveau Centre Ressource Lyonnais des Addictions Médicamenteuses (CERLAM). Ouvert le jeudi 19 mai à...
