Drug Approval | January 12, 2026
FDA rejects Vanda’s jet lag drug in current form
Vanda strongly disputes the FDA’s reasoning
Vanda strongly disputes the FDA’s reasoning
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
InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development
The acquisition marks a major step in PAI’s strategy to expand domestic pharmaceutical manufacturing
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
The decision follows an interim analysis conducted when roughly half of the patients had completed their Day 84 visit
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