UK – GSK’s Blenrep combination recommended by NICE to treat multiple myeloma
The health technology assessment agency has recommended in draft guidance that the antibody-drug conjugate be used on the NHS alongside bortezomib plus dexamethasone (BVd)...
Europe – PRAC concludes eye condition NAION is a very rare side effect of...
EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic anterior ischemic...
UK – NHS first in world to roll out new ‘trojan horse’ therapy for...
The NHS in England will be the first health system in the world to roll-out a ‘trojan horse’ targeted therapy for blood cancer patients...
France – Lévothyrox® : deux nouveaux dosages arrivent !
Deux dosages inédits inscrits au remboursement
Merck France annonce la commercialisation en septembre 2025 de deux nouveaux dosages de Lévothyrox® : 38 microgrammes et 63 microgrammes. Leur inscription sur la liste des médicaments...
USA – FDA drafts guidance, orders on minor changes to OTC drugs and packaging
The Food and Drug Administration (FDA) has released draft guidance and a proposed administrative order regarding the documentation required for minor dosage form changes...
UK – NICE recommends Sogroya for growth hormone deficiency in children
The National Institute for Health and Care Excellence (NICE) has recommended Sogroya (somapacitan injection) for children aged 3 to 17 years with paediatric growth...
Europe – EU Council adopts compromise position on pharma reforms
The European Council has taken its position on a package to reform the EU’s pharmaceutical sector, teeing up negotiations with the European Parliament on...
Europe – New guideline on inclusion of pregnant and breastfeeding individuals in clinical trials
EMA has released for public consultation a new guideline providing recommendations on how to include and/or retain pregnant and breastfeeding people in clinical trials. The goal is to...
USA – FDA approves darolutamide for metastatic castration-sensitive prostate cancer
On June 3, 2025, the Food and Drug Administration (FDA) approved darolutamide (Nubeqa, Bayer Healthcare Pharmaceuticals Inc.) for metastatic castration-sensitive prostate cancer (mCSPC). The...
UK – NICE recommends mirikizumab for Crohn’s disease treatment
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active...
