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 agreement responds directly to President Trump’s demands that drugmakers cut costs for US patients
The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit
ALV-100 is a bifunctional fusion protein combining glucose-dependent insulinotropic polypeptide receptor (GIPR) antagonism with glucagon-like peptide-1 receptor agonism
Nxera will take full responsibility for regulatory approvals, clinical development where required, manufacturing and commercialization in the licensed territories
The agreement, signed in December 2025, grants Takeda an exclusive worldwide license to use Halozyme’s proprietary recombinant human hyaluronidase PH20 enzyme (rHuPH20) with vedolizumab
DME is among the most challenging retinal diseases to treat and has long served as a proving ground for therapies that ultimately become first-line standard of care in retinal diseases
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