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 grant will fund ten new J.MD projects over the next three years, targeting multiple global health threats
This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo to patients in France, Denmark, Iceland, Sweden, Finland and Norway
The therapy is mutation-agnostic and aims to overcome limitations of existing EGFR-targeting drugs by concentrating degradation in tumors while sparing healthy tissue
The multimillion-dollar facility combines discovery and early-phase scale-up capabilities with R&D labs and two pilot plants
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
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
InflaRx is streamlining operations and largely discontinuing non-essential activities outside izicopan’s development
KRAS G12C-mutant advanced or metastatic nonsquamous non-small cell lung cancer
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