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 Nuvalent buy delivers new cancer approval for GSK GSK has its first approval from the $10.6bn takeover of Nuvalent, ROS1+ NSCLC therapy Jideytro, which becomes the company's first lung cancer product.
Digital Sponsored Discover a new era of healthcare panel engagement: Grounded ... A new webinar from Konovo will address some of the critical topics impacting today’s healthcare market research industry.
