Europe – EMA starts review of sodium oxybate in alcohol dependence
EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal...
UK – MHRA approves UK’s first anti-PD-1 monoclonal antibody for treatment of aggressive form...
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 20 June 2025, approved serplulimab (Hetronifly) to treat adults with extensive-stage small cell lung...
Europe – First treatment against liver scarring caused by a type of ‘fatty liver...
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Rezdiffra (resmeritom) for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis...
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The health technology assessment agency has recommended in draft guidance that the antibody-drug conjugate be used on the NHS alongside bortezomib plus dexamethasone (BVd)...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...
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...
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The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active...
