News EU: Trials should include pregnant subjects where possible With new guidance, the EMA is seeking to ramp up the inclusion of pregnant and breastfeeding women in clinical trials.
News Amid staff cuts, FDA looks to AI to 'optimise' reviews The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
News Axe falls on Stealth Bio staff after FDA rejects lead drug Stealth BioTherapeutics' filing for Barth syndrome therapy elamipretide has been turned down by the FDA, but there may be a way forward for the drug.
News MSD and Daiichi Sankyo pull HER3-DXd's FDA filing MSD and Daiichi Sankyo suffer another setback with their HER3 programme ahead of a crucial data readout at ASCO.
News FDA fast-tracks Teva's coeliac disease treatment Teva gets fast-track status from the FDA for a coeliac disease drug with a mechanism that has proved tough to crack.
News Manufacturing issues scupper Savara's lead drug filing Savara shares are pummelled after the FDA says it cannot accept a filing for lead drug Molbreevi, but it is still hopeful of an approval in 2026.
News UK project addresses capacity issue in CGT manufacturing A UK consortium has been set up to tackle a major issue in the development of cell and gene therapies (CGT) – a lack of manufacturing capacity.
Market Access The value of a partner, globally and locally A new podcast looks at recent trends related to drug approvals, as well as challenges and opportunities both small and large pharma companies face
