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Cellenkos Receives FDA Clearance of Investigational New Drug (IND) Application for CK0803 for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

-- CK0803 are neurotropic, allogeneic, umbilical cord blood derived T regulatory (Treg) cells -- CK0803 represents the company's fifth program to receive IND Clearance utilizing Cellenkos' proprietary CRANEtechnology HOUSTON, Sept. 22, 2022 /PRNewswire/ -- Cellenkos, Inc., a clinical stage biotech company that focuses on developing transformative cellular therapeutics for treatment of inflammatory disorders and autoimmune diseases, today announced that the U.S. Food and Drug Administrati...
United States Tara Sadeghi Neil Shneider Cellenkos Inc Prnewswire Cellenkos Inc Center At Columbia University

Minerva Neurosciences, Inc: Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

WALTHAM, Mass., Aug. 22, 2022(Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced that the
United States Helen Shik Remy Luthringer Frederick Ahlholm Minerva Neurosciences Exchange Commission

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Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia

WALTHAM, Mass., Aug. 22, 2022 -- Minerva Neurosciences, Inc. , a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today... | August 22, 2022
United States Helen Shik Remy Luthringer Frederick Ahlholm Minerva Neurosciences Exchange Commission

Horizon Therapeutics plc: FDA Approves KRYSTEXXA (pegloticase) Injection Co-Administered With Methotrexate, Expanding the Labeling to Help More People with Uncontrolled Gout Achieve a Complete Response to Therapy

-- Approval based on MIRROR randomized controlled trial, which showed significant improvement and sustained patient response to KRYSTEXXA with methotrexate compared to KRYSTEXXA alone -- -- Trial
United States Amanda Phraner Clin Rheumatol Tina Ventura Johnk Botson Ray Gordon

Innovent and Lilly Jointly Announce the Approval of TYVYT (sintilimab injection) by China NMPA in Combination with Chemotherapy as First-Line Treatment for Esophageal Squamous Cell Carcinoma

SAN FRANCISCO, INDIANAPOLIS and SUZHOU, China, June 21, 2022 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, and Eli Lilly and Company ("Lilly", NYSE: LLY) today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Ad...
United States Li Wang Hong Kong Rhui Zhou Shen Lin Innovent Biologics

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