Europe – New features further strengthen Priority Medicines scheme (PRIME)
EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of...
UK – Guidance published on the new international regulatory recognition routes for medicines approvals
Following announcement in May of the new scheme to replace the current EC Decision Reliance Procedure (ECDRP) on 1 January 2024, this guidance informs the sector on how...
USA – FDA approves second over-the-counter naloxone nasal spray for opioid overdose
The FDA’s decision means that RiVive stands as the second non-prescription, OTC naloxone nasal spray product that the agency has approved.
FDA commissioner, Robert Califf,...
USA – FDA issues last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
USA – Drugmakers ask FDA to reconsider concomitant treatment in migraine drug guidance
Four drugmakers have asked the US Food and Drug Administration (FDA) to amend some of the requirements in its draft guidance on developing migraine prevention...
USA – FDA approves first interchangeable biosimilars to Prolia and Xgeva to treat certain...
FDA approved Jubbonti (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Prolia (denosumab), and Wyost (denosumab-bbdz) injection as an interchangeable biosimilar to U.S.-licensed Xgeva...
Europe – EMA confirms measures to minimise the risk of serious side effects with...
PRES and RCVS are rare conditions that can involve reduced blood supply to the brain, potentially causing serious, life-threatening complications. With prompt diagnosis and...
UK – New T-cell study demonstrates ‘powerful’ potential for tailored cancer medicine
The clinical study involved 16 patients with either colon, breast or lung cancers that had failed to respond to other treatments, and was made...
USA – FDA issues emergency guidance to spur development of monkeypox tests
The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics...
France – Topiramate et risques chez les enfants exposés pendant la grossesse : modification...
Actualisation du 2 mai 2023
Depuis le 2 mai 2023, pour les filles, adolescentes, femmes en âge de procréer et femme enceintes :
La prescription de...
