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 FDA tightens heart tox warnings on mRNA COVID vaccines The FDA has instructed Pfizer and Moderna to add stronger warnings to the labels of their COVID-19 vaccines about the risk of cardiotoxicity.
News Mixed outcomes for pharma in big week for FDA adcomms There was good news for Johnson & Johnson at this week's ODAC meetings, but not for Roche, UroGen, and Pfizer.
News US imposes limits on COVID-19 boosters and new jabs The FDA has introduced a stricter set of policies around COVID-19 vaccines, including requiring clinical trials for new shots in some cases.
Oncology BioNTech’s ASCO 2025 oncology advances: New data on bispecif... At ASCO 2025, BioNTech presented 7 abstracts on four selected pipeline candidates in mesothelioma, lung cancer, prostate cancer, and melanoma.
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
