Drug Approval | May 30, 2026
FDA delays AstraZeneca decision on camizestrant as regulators seek more data
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The filing is backed by results from the pivotal SERENA-6 Phase III trial
The company is expected to conduct further studies to confirm the long-term efficacy and safety of Vijoice in both adult and paediatric patients
The decision now moves to the European Commission, with a final ruling expected by the third quarter of 2026
If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
The decision marks a key step in the centralized EU review process
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
Chronic GVHD is a serious and potentially life-threatening condition, imposing profound physical and emotional burdens on a substantial proportion of patients following allogeneic stem cell transplantation
AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible
The decision marks a pivotal moment for the Massachusetts-based biotech giant
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