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
If approved, TEV-‘749 would mark a shift toward long-acting care aimed at improving treatment adherence in real-world settings
The decision marks a key step in the centralized EU review process
SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization
The drug also delivered a disease control rate (DCR) of 83.3% in high-dose cohorts and a mean progression-free survival of 6.3 months in SCLC patients
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
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