SEONGNAM, South Korea — SN Bioscience Inc. (CEO Young Hwan PARK) announced that the FDA had granted Orphan Drug Designation (ODD) on December 10 for gastric cancer (including gastroesophageal junction cancer) to SNB-101 (API: SN-38) which is a polymer nanoparticle drug under phase 1b/2 clinical trial for small cell lung cancer....
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EONGNAM, South Korea — In a strong endorsement of its cutting-edge drug delivery technology, SN BioScience announced that its anticancer candidate SNB-101 has been selected as a clinical-stage project under the 2025 Korea Drug Development Project, a government-initiated program led by the Korea Drug Development Fund (KDDF). The program includes two years...
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...
Stockholm, Sweden – Sobi® (STO: SOBI), today announced that the European Commission (EC) has approved Aspaveli® (pegcetacoplan) for the treatment of adult and adolescent patients aged 12 to 17 years with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS...
WALTHAM, Mass. — Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) announced today that Health Canada has approved EMPAVELI® (pegcetacoplan), a complement inhibitor, for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria. EMPAVELI® is a targeted C3 therapy...
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...
DULLES, Va. — SOFIE Biosciences, an established U.S. manufacturer and developer of radiopharmaceuticals, today announced that the first patient has been dosed in the second of its two Phase 3 clinical trials evaluating [18F]FAPI-74, a fluorine-18 labeled radiopharmaceutical targeting Fibroblast Activation Protein (FAP), as a novel diagnostic for patients with Pancreatic Ductal...
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%)...