www.ema.europa.eu [ad_1] 12 new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting. The committee recommended granting a marketing authorisation for Frehemgo (denecimig), for the prophylaxis of bleeding...

www.ema.europa.eu [ad_1] CVMP opinions on veterinary medicinal products  The Committee adopted a positive opinion for a marketing authorisation for Cirbloc, for the active immunisation of pigs from three weeks of age to reduce viraemia, virus load in the lungs and lymphoid tissues, and virus...

www.ema.europa.eu [ad_1] Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicines EMA’s safety committee, PRAC, has started a review of injectable iron-containing medicines following concerns about the risk of hypophosphataemia (low blood...

www.ema.europa.eu [ad_1] Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availability of Visudyne has impacted the planning, prioritisation and prescribing of patient treatment. Once the shortage is fully...

www.ema.europa.eu [ad_1] EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have the potential to provide information comparable to, or better than current testing approaches,...