Nasdaq

FDA Approves HETLIOZ® (tasimelteon) for the Treatment of Nighttime Sleep Disturbances in Smith-Magenis Syndrome

WASHINGTON, Dec. 1, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved HETLIOZ® (tasimelteon) capsule ...
Business Insider

Vanda Announces Positive Pivotal Study Results for HETLIOZ® (tasimelteon) in Patients with Smith-Magenis Syndrome

WASHINGTON, Dec. 10, 2018 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that HETLIOZ ® (tasimelteon) improved sleep quality and increased sleep duration in patients ...
Nasdaq

FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ® (tasimelteon) in the Treatment of Smith-Magenis Syndrome

WASHINGTON, Aug. 3, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review Vanda's ...
Monthly Prescribing Reference

FDA to Review Tasimelteon for Smith-Magenis Syndrome

Pexidartinib is an oral small molecule that is believed to work by inhibiting colony stimulating factor-1 receptor (CSF1R). The applications are supported by positive results from a double-masked, ...
Business Insider

Vanda Pharmaceuticals Announces Agreement with FDA on Resubmission of the Application for HETLIOZ® for the Treatment of Patients with Smith-Magenis Syndrome

WASHINGTON, May 13, 2020 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that following the completion of a Type A Meeting with the U.S. Food and Drug Administration ...
Morningstar

Health Canada Approves Slenyto® - Extended-Release Melatonin Formulation - as a Prescription Drug for Insomnia in Children with Autism Spectrum disorder and Smith Magenis Syndrome

Health Canada Approves Slenyto® - Extended-Release Melatonin Formulation - as a Prescription Drug for Insomnia in Children with Autism Spectrum disorder and Smith Magenis Syndrome ...
EurekAlert!

Reversing Smith-Magenis syndrome symptoms

Researchers report that restoring RAI1 gene expression levels during an early age-window partially reversed gene expression and social interaction deficits in a mouse model of Smith-Magenis syndrome ...
The Business Journals

Vanda steps closer to potential FDA approval for rare developmental disorder treatment

To continue reading this content, please enable JavaScript in your browser settings and refresh this page. The decision comes after the D.C. biotech and the FDA ...
WDRB

Corn hole tournament at 3rd Turn Brewing raises awareness for Smith Magenis Syndrome

LOUISVILLE, Ky. (WDRB) -- A corn hole tournament in Oldham County raised awareness for a rare syndrome. 3rd Turn Brewing in Crestwood hosted the Nickels for Nico tournament for the 13th year. The ...
WGN-TV

Chicago Scene: One For The Kids – fundraiser for Smith-Magenis Syndrome

One for the Kids was established in 1993 by a group of concerned individuals who wanted to make a difference. Our first event was held at Old Oaks Golf course and raised a few thousand dollars. Since ...
ABC News

Syndrome Makes Boy Cry When He Hears Music

Louis Mushrow suffers from Smith-Magenis syndrome. Sept. 20, 2013— -- Every time Louis Mushrow, 9, hears certain songs, he beings to cry. But his tears aren't related to hearing sad songs, ...