Today, we celebrate the impact of an engaged patient community, and we are grateful to the FDA and Reata for working together on the approval of SKYCLARYS, the first therapy approved in the United ...

(RTTNews) - Biogen Inc. (BIIB) said that the European Commission has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

Friedreich’s ataxia is a rare, genetic, life-shortening, debilitating, and neurodegenerative disorder Treatment with SKYCLARYS improved patient function compared to placebo Biogen is leveraging its ...

- PTC's fourth approval application submitted to FDA in 2024 - WARREN, N.J., Dec. 19, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (PTCT) announced today the submission of the vatiquinone New Drug ...

Please provide your email address to receive an email when new articles are posted on . Skyclarys was approved in the U.S. for Friedreich’s ataxia in 2023. Approval was based on positive results from ...

WARREN, N.J., Feb. 19, 2025 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA ...

CAMBRIDGE, Mass., Dec. 15, 2023 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended ...