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
The deal brings Labcorp’s U.S. portfolio—including biocompatibility, microbiological, and analytical testing, as well as preclinical research—under NAMSA’s roof
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
New 35,000-square-foot facility in Winter Park will expand RLT manufacturing footprint to optimize delivery for patients across southeastern US
The partnership aims to develop a first-in-class broad-spectrum antifungal to combat life-threatening invasive infections
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
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