International regulators have published a report highlighting their considerations on the development, clinical trials and availability of vaccines and therapeutics for mpox. The report presents the outcomes of a workshop…
Ten new medicines recommended for approvalThe committee recommended granting a marketing authorisation for Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with haemophilia A or B with…
EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2024 no later than 30 November 2024. This will enable EMA to acknowledge the validity…
After re-examining its initial opinion, EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation to Leqembi (lecanemab) for treating mild cognitive impairment (memory and thinking problems) or mild…
EMA's Committee for Veterinary Medicinal Products (CVMP) has issued the first certificate for a vaccine platform technology master file (vPTMF) which will support and accelerate the development and authorisation of…
