Business Wire

Reata Pharmaceuticals Announces FDA Approval of SKYCLARYS™ (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia

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 ...
Nasdaq

Biogen's Skyclarys Approved In Europe For Friedreich's Ataxia Treatment

(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.
Drug Store News

Reata receives FDA OK for Skyclarys

Reata Pharmaceuticals has received permission from the Food and Drug Administration for Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and ...
Healio

European Commission approves Skyclarys for Friedreich’s ataxia

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 ...
Nasdaq

Bionano Genomics Announces First Publication Using OGM for Detection of Repeat Expansions in CANVAS and Adult-Onset Ataxia

SAN DIEGO, Aug. 11, 2022 (GLOBE NEWSWIRE) -- Bionano Genomics, Inc. (Nasdaq: BNGO) today announced the publication of the first study to evaluate the utility of optical genome mapping (OGM) in the ...
Seeking Alpha

CHMP Issues Positive Opinion for Biogen’s SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia, a Rare Neurodegenerative Disease

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 ...
Seeking Alpha

PTC Therapeutics Announces Vatiquinone NDA Submission to FDA for the Treatment of Children and Adults Living with Friedreich Ataxia

- 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 ...
Monthly Prescribing Reference

Vatiquinone Gets Priority Review for Friedreich Ataxia

A Prescription Drug User Fee Act target date of August 19, 2025 has been set for the application. The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) ...
Healio

FDA requests more studies before approving vatiquinone for Friedreich’s ataxia

Please provide your email address to receive an email when new articles are posted on . Vatiquinone inhibits 15-Lipoxygenase, which regulates the pathways that Friedreich’s ataxia disrupts. PTC ...
Longview News-Journal

PTC Therapeutics Announces FDA Acceptance and Priority Review for Vatiquinone NDA for the Treatment of Children and Adults with Friedreich's Ataxia

"We are excited to be one step closer to bringing an approved therapy to all patients with Friedreich's ataxia," said Matthew B. Klein, M.D., Chief Executive Officer of PTC Therapeutics. "If approved, ...
MedPage Today

Difficulty Walking, Severe Anxiety Point to Spectrum of Neurological Diagnoses

What is causing this 55-year-old woman to have distorted speech and balance problems when walking, and why have her symptoms worsened progressively since they came on 14 years ago? Those are the ...