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The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active...
UK – NICE recommends sparsentan for IgA nephropathy
The National Institute for Health and Care Excellence (NICE) has recommended FILSPARI (sparsentan) for use in the NHS in England as a treatment for...
UK – AstraZeneca’s Forxiga recommended by NICE for wider chronic kidney disease use
The health technology assessment agency has recommended that the drug be used on the NHS to treat CKD in adults if it is an...
USA – FDA proposes downgrading drug color additive changes to CBE-30
The US Food and Drug Administration (FDA) has released draft guidance for pharmaceutical manufacturers wishing to replace a color in a drug product. These...
International – ICH releases guidelines on developing medicines for pregnant population and quality information...
The International Council for Harmonisation (ICH) has recently released two draft guidelines for public consultation. One draft guideline focuses on assessing new drugs for...
Europe – Changes to the use of antibiotic azithromycin
EMA’s human medicines committee (CHMP) has recommended several changes to the way the antibiotic azithromycin is used in the EU, including the removal of...
