FDA to review Regenxbio’s gene therapy BLA for Hunter syndrome
The agency has granted the application priority review, setting a Prescription Drug User Fee Act (PDUFA) target action date of 9 November 2025. The therapy has secured several
This fixed-dose combo of Perjeta (pertuzumab) and Herceptin (trastuzumab), delivered via SC injection along with intravenous chemotherapy, offers a subcutaneous (SC) treatment option for human epidermal growth factor
This agreement designates Er-Kim as the distributor for the therapy in Azerbaijan, Armenia, Belarus, Georgia, Kyrgyzstan, Kazakhstan, Uzbekistan, Tajikistan, Russia, and Turkmenistan. The prescription medicine, Nerlynx, is intended