SAN FRANCISCO, Calif. — Today marks a turning point in the battle against Alzheimer’s disease as Darmiyan, Inc., a leading company in brain health innovation announces the FDA’s approval of its first-in-class (De Novo) clinical test, BrainSee. This approval marks a pivotal advancement in brain health and opens the door to...
treatment News
BEERSE, Belgium – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the European Commission (EC) has granted marketing authorisation for the expanded use of DARZALEX®▼ (daratumumab) subcutaneous (SC) formulation in two new indications. The first authorisation of these new indications is for the use of daratumumab SC in...
MECHELEN, Belgium, — Interim results from an ongoing phase 2, randomized, placebo-controlled trial of the investigational drug TMC207 for the treatment of multidrug-resistant tuberculosis (MDR-TB) were published in the New England Journal of Medicine today. TMC207 is being developed by Tibotec BVBA. The data show that the addition of TMC207...
Data Analysis Supports Use of Predictive Enrichment Markers in Phase 2b OraGrowtH210 Trial AUSTIN, Texas – Lumos Pharma, Inc., a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced that results of peer-reviewed analyses of data from two prior pediatric growth hormone deficiency (PGHD) studies have been published in...
TOKYO & MUNICH & BASKING RIDGE, N.J. – New data for datopotamab deruxtecan (Dato-DXd), a TROP2 directed DXd antibody drug conjugate (ADC) being developed by Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca, show an encouraging tumor response rate in patients with advanced non-small cell lung cancer (NSCLC) with...
BRISBANE, Calif. – Day One Biopharmaceuticals Inc. (Nasdaq: DAWN), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment...
LAUSANNE, Switzerland – Debiopharm (www.debiopharm.com), a Swiss-based global biopharmaceutical company, today announced the signature of an exclusive license agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, for the development and commercialization of xevinapant (Debio 1143). Xevinapant, a potent, oral of Inhibitor of Apoptosis Proteins (IAP) antagonist,...
Boston — Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, announced that the European Medicines Agency (EMA) Committee on Orphan Medicinal Products (COMP) has issued a positive opinion on orphan drug designation for DB-OTO, Decibel’s lead...
NEW YORK — Delcath Systems, Inc. (NASDAQ: DCTH) , a medical technology company testing its proprietary treatment method for primary and metastatic cancers to the liver, announced today that the United States Food and Drug Administration (“FDA”) granted Delcath’s application for orphan-drug designation for the drug melphalan for the treatment...
TOKUSHIMA, Japan — As presented at 2022 ASCO Annual Meeting on June 6, 2022, DFP-14323 in combination with afatinib (20 mg/day) in stage III/IV non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) mutation positive in a Phase II clinical trial, has demonstrated fascinating longer median progression-free survival...