Sunday, January 26, 2020

Sunday, January 26, 2020

Latest News

CLENE NANOMEDICINE: Announces Formal Acceptance of CNM-Au8 for HEALEY ALS Platform Trial as Center Receives FDA Approval to Proceed

Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, today announced the receipt of formal acceptance from the U.S. Food and Drug Administration (FDA) to proceed with its CNM-Au8 as one of the first three drug regimens in the HEALEY ALS Platform Trial being conducted by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital.

BAZE: Boston-Based Personalized Nutrition Startup, Baze, Announces FDA Approval For Blood-Based Testing Kits

Regulatory approval enables company to expand reach of at-home kits, empowering consumers nationwide to take control of their health

BIOHAVEN PHARMACEUTICALS: Biohaven's Verdiperstat Receives FDA May Proceed Letter To Initiate Trial In Amyotrophic Lateral Sclerosis Conducted By The Healey Center For ALS At Mass General

Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven" or the "Company"), a biopharmaceutical company with multiple late-stage neuroscience drug candidates in development, announced today that the U.S. Food and Drug Administration (FDA) has notified its collaborators at the Sean M. Healey & AMG Center for Amyotrophic Lateral Sclerosis (ALS) at Massachusetts General Hospital (MGH) that they may proceed with clinical investigation of verdiperstat, Biohaven's novel myeloperoxidase (MPO) inhibitor, in ALS.

CELULARITY: Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

Company to Initiate First U.S. Clinical Investigation of Allogeneic NK Cell Therapy administered Intravenously or Intratumorally in Patients with Glioblastoma Multiforme (GBM)

THE FCS FOUNDATION: Familial Chylomicronemia Syndrome Foundation Commends FDA Decision to Create New Advisory Group to Support Rare Disease Drug Review Processes

Action aligns with requests from FCS Foundation for FDA to be more flexible and hear the patient voice when considering review of drugs to treat FCS

VIVALNK: Announces World's First FDA Cleared Wearable ECG Sensor Platform

Reusable patch and software development kit gives solution providers direct control over data

FDA Reporter