FDA Priority Review of DCCR for PWS: Latest Update and What It Means
On October 8, 2024, Soleno Therapeutics provided a regulatory update onย DCCR (Diazoxide Choline Controlled-Release)ย tablets, which are currently undergoingย priority review by the FDAย as a potential treatment for hyperphagia in individuals with Prader-Willi syndrome (PWS). Although the FDA has moved forward with priority review, it has chosen not to hold anย advisory committee meetingย at this time. We have...
Spreading Joy: Operation Holiday Cheer Returns to Support PWS Families in 2024
THE APPLICATION DEADLINE HAS PASSED. WE ARE NO LONGER ACCEPTING OPERATION HOLIDAY CHEER APPLICATIONS. ————————————————————————————————————— Thanks to the incredible generosity of an anonymous donor, PWSA | USA is thrilled to bring back Operation Holiday Cheer for 2024! This heartwarming initiative helps spread joy to families in need by easing the financial burden of the holiday...
PWSA | USA’s Podcast has a New Name!
As part of our ongoing efforts to best serve the Prader-Willi syndrome community, we are introducing a new name for our podcast. Moving forward, PWSA | USAโs podcast will be known as PWS United! This change is based on valuable feedback we’ve received from the community. Some members are sharing there is occasional confusion between...
FDA Accepts Application for New Drug DCCR, Moves to Priority Review
Exciting news for the Prader-Willi syndrome (PWS) community! Soleno Therapeutics has announced that the FDA has accepted their new drug application (NDA) for DCCR, a drug designed to treat hyperphagia in individuals with PWS aged 4 and older. This acceptance is a major first step, and the FDA has granted Priority Review, recognizing the potential...
Perry A. Zirkel has written more than 1,500 publications on variousย aspects of school law, with an emphasis on legal issues in special education.ย He writes a regular column for NAESPโsย Principalย magazine and NASPโsย Communiquรฉย newsletter, and he did so previously forย Phi Delta Kappanย andย Teaching Exceptional Children.
Jennifer Bolander has been serving as a Special Education Specialist for PWSA (USA) since October of 2015. She is a graduate of John Carroll University and lives in Ohio with her husband Brad and daughters Kate (17), and Sophia (13) who was born with PWS.
Dr. Amy McTighe is the PWS Program Manager and Inpatient Teacher at the Center for Prader-Willi Syndrome at the Childrenโs Institute of Pittsburgh. She graduated fromย Duquesne University receiving her Bachelorโs and Masterโs degree in Education with a focus on elementary education, special education, and language arts.
Evan has worked with the Prader-Willi Syndrome Association (USA) since 2007 primarily as a Crisis Intervention and Family Support Counselor. Evans works with parents and schools to foster strong collaborative relationships and appropriate educational environments for students with PWS.
Staci Zimmerman works for Prader-Willi Syndrome Association of Colorado as an Individualized Education Programย (IEP) consultant. Staci collaborates with the PWS multi-disciplinary clinic at the Childrenโs Hospital in Denverย supporting families and school districts around the United Statesย with their childโs Individual Educational Plan.
Founded in 2001, SDLC is a non-profit legal services organization dedicated to protecting and advancing the legal rights of people with disabilities throughout the South. It partners with the Southern Poverty Law Center, Protection and Advocacy (P&A) programs, Legal Services Corporations (LSC) and disability organizations on major, systemic disability rights issues involving the Individuals with Disabilities Education Act (IDEA), Americans with Disabilities Act (ADA), and the federal Medicaid Act. Recently in November 2014, Jim retired.