BOSTON, MASS. — Servier today announced longer-term data from the Phase 3 INDIGO trial evaluating VORANIGO® (vorasidenib) versus placebo in patients with Grade 2 mutant isocitrate dehydrogenase 1 or 2 (mIDH1/2) glioma following surgical intervention and for whom chemoradiotherapy can be delayed were published in The Lancet Oncology. The analysis reports an additional six months of...
treatment News
BOSTON, Mass. — Servier today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the approval of VORANIGO® (vorasidenib) in the European Union (EU) for the treatment of predominantly non-enhancing Grade 2 astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1)...
VALENCIA, Calif. — SetPoint Medical, a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the use of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS). Breakthrough...
Pittsburgh, Pennsylvania and Toronto, Ontario – Sharp Therapeutics Corp. (TSXV: SHRX) (“Sharp” or the “Company”), a preclinical-stage biotechnology company developing small molecule therapies to treat genetic diseases, today announced that it has engaged Rho, Inc. (“Rho”), a global contract research organization (CRO), to support Sharp’s preparation and planned submission of...
CLONMEL, Ireland – Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced today that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the...
PRINCETON, N.J. & TOKYO & WALTHAM, Mass. — Otsuka Pharmaceutical Development & Commercialization, Inc., (OPDC); Otsuka Pharmaceutical, Co. Ltd. (Otsuka); and Visterra, Inc., an Otsuka group company announce that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug sibeprenlimab for the treatment of...
— Successfully demonstrates strong tolerability, sustained drug release and safety SARASOTA, Florida — Silo Pharma, Inc. (Nasdaq: SILO) (“Silo,” or the “Company”), a developmental stage biopharmaceutical company focused on novel therapeutics and drug delivery systems, today announced positive results for its preclinical study evaluating SP-26, a novel extended-release ketamine...
BEIJING, China — SineuGene Therapeutics, a clinical-stage biotechnology company focused on gene therapies for neurological diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its gene therapy, SNUG01, for the treatment of amyotrophic lateral sclerosis (ALS). SNUG01 is a first-in-class gene therapy targeting...
Baltimore, Maryland – A single dose of the typhoid conjugate vaccine, Typbar TCV®, provides lasting efficacy in preventing typhoid fever in children ages 9 months to 12 years old, according to a new study conducted by researchers at University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and...
New long-term CARTITUDE-1 data show one-third of patients treated with CARVYKTI® remain progression-free CARTITUDE-4 analysis shows compelling overall survival and progression-free benefits in standard and high-risk subgroups across prior lines of treatment CHICAGO, Ill. — Johnson & Johnson (NYSE:JNJ) announced today new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating 33 percent...