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)...
treatment News
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...
DUBLIN, Ireland — Prothena Corporation plc (NASDAQ:PRTA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to coramitug, a potential best-in-class amyloid depleter antibody currently in Phase 3 development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Fast Track Designation is intended to...
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,...
PLAINSBORO, N.J. and BAGSVÆRD, Denmark — Novo Nordisk today unveiled new data from the phase 3 FRONTIER4 extension study evaluating the long-term safety and efficacy of investigational denecimig (Mim8) subcutaneous prophylaxis in children, adolescents, and adults with hemophilia A, with or without inhibitors, across a range of dosing frequencies including once-monthly, once-every-two-weeks,...
Bagsværd, Denmark – Novo Nordisk today announced the headline results from the kidney outcomes trial FLOW. The announcement today follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial...
PLAINSBORO, N.J. and BAGSVÆRD, Denmark — Novo Nordisk today announced that phase 3b results from the FRONTIER5 study of investigational denecimig were published in the Journal of Thrombosis and Haemostasis. The 26-week results showed that a direct switch to the subcutaneous denecimig pen injector from the emicizumab vial and syringe injection...
ROOT, Switzerland — NovoCure Ltd. (NASDAQ: NVCR) today announced that the final patient has been enrolled in the global phase 3 TRIDENT clinical trial evaluating the safety and efficacy of initiating Optune Gio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients...