Reston, VA — A new molecular imaging technique that pairs a novel tracer with a next-generation PET/CT scanner can identify neuroblastoma in children with high sensitivity, requiring a scan time of only minutes and no sedation or anesthesia. With its ability to accurately diagnose neuroblastoma, this technique, known as 18F-MFBG LAFOV...
treatment News
Vienna, Austria – Groundbreaking research presented today at UEG Week 2024 reveals a promising new treatment strategy for type 2 diabetes (T2D) that could significantly reduce or even eliminate the need for insulin therapy.1 This innovative approach, which combines a novel procedure known as ReCET (Re-Cellularization via Electroporation Therapy) with...
WEST LAFAYETTE, Ind. — Purdue University researchers are developing and validating a patent-pending treatment for incurable glioblastoma brain tumors. Glioblastomas are almost always lethal with a median survival time of 14 months. Traditional methods used against other cancers, like chemotherapy and immunotherapy, are often ineffective on glioblastoma. Sandro Matosevic, associate...
Reston, VA—A new radiotheranostic system has the ability to detect and treat ovarian cancer noninvasively, according to new research published in the April issue of The Journal of Nuclear Medicine. Combining the highly specific huAR9.6 antibody with PET and therapeutic radionuclides, this theranostic platform may provide more personalized treatment to improve...
CLEVELAND, Ohio — NovelMed today announced that the U.S. Food and Drug Administration (FDA) has awarded Orphan Drug Designation (ODD) to NM5072, an Alternative Pathway (AP) blocker anti-Properdin antibody, for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH). NM5072 is being developed for PNH patients in the United States...
CLEVELAND, Ohio — NovelMed Therapeutics Inc., a clinical-stage biopharmaceutical company specializing in alternative pathway (AP) complement-mediated therapies, today announced two major milestones in the clinical development of Ruxoprubart (NM8074) for Paroxysmal Nocturnal Hemoglobinuria (PNH). The company has received regulatory clearance to initiate a Phase II study for the subcutaneous (SC)...
CLEVELAND, OHIO— NovelMed Therapeutics, Inc. today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Ruxoprubart, an alternative pathway (AP) blocker anti-Bb antibody, for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). FDA’s recognition of Ruxoprubart as an orphan drug for PNH underscores its potential...
PLAINSBORO, N.J. — Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved three new indications for once-weekly Sogroya® (somapacitan-beco) injection 5 mg, 10 mg, or 15 mg, a long-acting growth hormone.1 Sogroya® is now indicated for children aged 2.5 years and older with Idiopathic Short Stature (ISS), short stature...
Bagsværd, Denmark – Novo Nordisk today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo® (concizumab) label to include the treatment of severe hemophilia A and moderate or severe haemophilia B without inhibitors. “If...
BAGSVÆRD, Denmark and PLAINSBORO, N.J. — Today, Novo Nordisk announced Mim8 (denecimig) has been submitted for review to the U.S. Food and Drug Administration (FDA) through a Biologics License Application (BLA), a formal request to evaluate a biologic medicine. Denecimig is an investigational, next-generation bispecific antibody Factor VIIIa (FVIIIa) mimetic,...