21 October 2025
21 October 2025
The bispecific鈥檚 efficacy and safety will now be explored through a Phase III trial in first-line HNSCC.
The approval marks the first pharma-based therapy option that does not require corneal removal.
The approval is grounded in the findings of the Phase II NOBILITY and Phase III REGENCY studies.
The collaboration will utilise Lundbeck's neuroscience experience and Contera Pharma's oligonucleotide expertise.
The new scheme slashes FDA review times to 1-2 months for eligible drug candidates.
The availability of a rule-in-rule-out test for Alzheimer鈥檚 disease in primary care settings is likely to drive efficiencies throughout the care continuum.
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