FDA to review Kowa Pharmaceuticals’ NDA for glaucoma eye drop K-911
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of 30 April 2027. Also known as bimatoprost grenod or NCX 470, K-911 is
The regimens include Ziihera combined with Tevimbra (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy for patients with HER2+ immunohistochemistry (IHC) 3+ or IHC 2+/in situ hybridisation (ISH)+. The other
This regulatory status is designed for therapies targeting rare, life-threatening, or chronically debilitating diseases. Cushing’s syndrome of endogenous origin is a rare endocrine disease caused in most instances