News Just how radical is the FDA's complete response letter move? The FDA says publishing complete response letters for medicines is an act of "radical transparency," but it is not as revolutionary as it seems.
News UK authority cracks down on weight-loss drug ads Nine adverts for weight-loss services have been banned by the Advertising Standards Authority in the UK for promoting prescription-only drugs.
News Novo Nordisk files high-dose Wegovy in EU Novo Nordisk has moved quickly to file for approval of a higher-dose version of obesity drug Wegovy as it fends off stiff competition from Eli Lilly.
News J&J bids to extend prostate cancer uses for Akeega J&J is hoping the AMPLITUDE study results will make Akeega the first drug in the PARP inhibitor class for castration-sensitive prostate cancer.
Market Access One in five expressions of interest in UK regulator's pilot ... The MHRA, will be running five pilot dialogues as part of its first year exploring a real-world evidence scientific dialogue programme.
Market Access Balancing efficiency with risks: How biopharma companies can... AI technologies can enable companies to program, rather than write, submissions to health authorities.
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