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The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending mirikizumab (Omvoh) for adults with moderately to severely active...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The US Food and Drug Administration (FDA) has released draft guidance for pharmaceutical manufacturers wishing to replace a color in a drug product.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...
Europe – EMA starts review of ipidacrine-containing medicines
EMA’s human medicines committee (CHMP) has started a review of medicines containing ipidacrine. These medicines have been authorised in several EU countries through national...
Europe – New treatment for adults with acute lymphoblastic leukaemia
EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Aucatzyl (obecabtagene autoleucel) to treat adults from 26 years of age with relapsed...
