The FDA has delayed its ruling on AstraZeneca’s camizestrant (camizestrant) breast cancer drug after a negative advisory committee vote, pushing the agency’s decision to consider new analyses submitted following the panel. The setback keeps pressure on AstraZeneca as it seeks to move camizestrant forward in settings where endocrine resistance remains a major unmet need. Separately, EMA’s CHMP recommended several new medicines at its May meeting, including oral semaglutide (Wegovy) label extensions and a positive opinion on AstraZeneca’s Etcamah camizestrant (an oral SERD) in combination with a CDK4/6 inhibitor for ER+/HER2- ESR1-mutant advanced or metastatic breast cancer. If approved by the European Commission, it would be positioned as a first oral SERD in that line of therapy. Together, the developments underscore how rapidly camizestrant’s regulatory pathway is diverging across jurisdictions—timing in the U.S. versus label expansion momentum in Europe.