A Prescription Drug User Fee Act target date of February 28, 2026 has been set for the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ...
Please provide your email address to receive an email when new articles are posted on . Idebenone has a Prescription Drug User Fee Act date of Feb. 28, 2026. Positive results in the phase 3 RHODOS and ...
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending idebenone (Raxone, Chiesi Pharmaceuticals) for treating visual impairment from Leber ...
FDA grants Priority Review to idebenone for Leber Hereditary Optic Neuropathy (LHON), a disease for which there are no existing approved treatments in the U.S.; action date of February 28, 2026 PARMA, ...