The drug targets relapsed or refractory primary central nervous system lymphoma, a rare and aggressive form of non-Hodgkin lymphoma
Hongene will focus on developing and scaling production of key capping reagents—essential components of mRNA therapeutics—emphasizing accessibility, transparency, and global deployment
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026
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 portfolio, purchased from a leading multinational generic manufacturer, addresses a market valued at $473.2 million for the 12 months ending August 2025
Imsidolimab, an IgG4 IL-36 receptor antagonist, works by inhibiting IL-36 receptor signaling, directly addressing the deficiency in the IL-36RA regulator common in GPP patients
If approved, CUTX-101 will be the first and only FDA approved treatment available for Menkes disease
Her journey includes leading HR for large and diverse teams across sales, marketing, corporate functions, and R&D
Growing patent filings and tier-2 innovators reflect expanding national research base
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