The facility will manufacture the critical antibiotic intermediate Amino Cephalosporanic Acid (ACA), a key component in the production of cephalosporin antibiotics
The initiative will focus on creating healthier early-life environments, promoting physical activity, identifying risks early, and strengthening preparedness within primary health care systems
Brivaracetam Oral Solution (10 mg/mL) is a prescription antiepileptic drug (anticonvulsant) used for treatment of partial-onset seizures in patients 1 month of age and older
If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations
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
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