USA – FDA expands types of acceptable confirmatory evidence in new guidance
In a new draft guidance, the US Food and Drug Administration (FDA) outlined the types of confirmatory evidence it will accept from sponsors that...
France – Médicaments à base de miansérine : rappel du bon usage et des...
Ces dernières années, des signalements d’usage non conforme de miansérine, dans la prise en charge de troubles du sommeil, chez des patients sans...
USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels
In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these...
UK- Pfizer’s Vydura recommended by NICE for acute migraines
The National Institute for Health and Care Excellence (NICE) has recommended Pfizer’s Vydura (rimegepant) as a cost-effective option for the treatment of acute migraines...
France – La campagne de vaccination contre le Covid-19 avancée au 2 octobre alors...
Face à une augmentation de la circulation du virus responsable du Covid-19, le ministre de la santé, Aurélien Rousseau, a décidé d’avancer la campagne...
Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP)...
Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its September 2023 meeting.
The CHMP recommended granting a marketing authorisation for Ebglyss (lebrikizumab), for...
France – L’ANSM classe plusieurs vaccins sur la liste I des substances vénéneuses
L’ensemble des vaccins, à l’exception des vaccins grippaux, est désormais classé sur la liste I des substances vénéneuses, à la suite d’une décision de...
Europe – EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep
EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer...
Europe – EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna
EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease...
USA – FDA issues draft guidance of clinical pharmacology, labeling considerations for peptide drug...
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s clinical pharmacology and labeling considerations for peptide drug products.
When...
