WALTHAM, Mass. — Sobi North America, the North American affiliate of Swedish Orphan Biovitrum AB (Sobi®), today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for avatrombopag (DOPTELET®) for the treatment of thrombocytopenia in pediatric patients one year and older with...
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STOCKHOLM, Sweden – Sobi® (STO: SOBI) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the marketing authorisation of Aspaveli® (pegcetacoplan) for the treatment of adult and adolescent patients with C3 glomerulopathy (C3G) or primary immune-complex...
WELLAND — While 12-year-old Andrew Lanese hasn’t been well enough to attend St. Alexander Catholic School, his fellow students and staff still consider him to be a part of their team that went out on the soccer fields Tuesday. The school hosted the first, of what is hoped to become...
Boston, MA – Freezing is one of the most common and debilitating symptoms of Parkinson’s disease, a neurodegenerative disorder that affects more than 9 million people worldwide. When individuals with Parkinson’s disease freeze, they suddenly lose the ability to move their feet, often mid-stride, resulting in a series of staccato...
NESS ZIONA, Israel — Sol-Gel Technologies, Ltd. (Nasdaq: SLGL) (“Sol-Gel”), a dermatology company leveraging innovative approaches to develop pioneering treatments for patients with severe skin conditions, and with two approved large-category dermatology products, TWYNEO® and EPSOLAY®, today announced that it has begun Phase 3 testing of SGT-610 (patidegib gel, 2%)...
REDWOOD CITY, Calif. – Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it has signed a collaboration agreement with Vanderbilt University. This collaboration aims to discover and develop novel KATP channel activators with the potential to treat rare diseases....
REDWOOD CITY, Calif. – Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, announced top-line results from the Company’s ongoing open-label extension study, C602, evaluating investigational, once-daily DCCR (Diazoxide Choline) Extended-Release tablets for patients with Prader-Willi syndrome (PWS) and its...
REDWOOD CITY, Calif. — Soleno Therapeutics, Inc. (Soleno) (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today highlighted new data on VYKATTM XR (diazoxide choline) extended-release tablets, previously known as DCCR, at the 2025 United in Hope: International Prader-Willi Syndrome Conference. “We believe that these...
A recent analysis of Phase 3 DESTINY PWS limited to data collected before the onset of the COVID-19 pandemic shows statistical significance in the primary and key secondary endpoints REDWOOD CITY, Calif., Feb. 05, 2021 – Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for...
EDWOOD CITY, Calif., – Soleno Therapeutics, Inc. (“Soleno”), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today provided an update following recent interactions with the U.S. Food and Drug Administration (FDA) regarding the development of once-daily DCCR (diazoxide choline) extended release tablets for the treatment...