Drug Approval | January 12, 2026
The clearance marks a major step in Diabeloop’s ambition to become a central partner for insulin pump manufacturers and expand access to automated insulin delivery in the US market
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
Supports production of AbbVie's current and next-generation immunology and neuroscience medicines
The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants
New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
ALV-100 is a bifunctional fusion protein combining glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism with glucagon-like peptide-1 receptor agonism
The partnership aims to develop a first-in-class broad-spectrum antifungal to combat life-threatening invasive infections
The agreement responds directly to President Trump’s demands that drugmakers cut costs for US patients
Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories
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