REDWOOD CITY, Calif. — Juvena Therapeutics, a biotechnology company unlocking the potential of stem cell-secreted proteins to treat muscle and metabolic diseases including muscular dystrophies and obesity, today announced the U.S. Food and Drug Administration (FDA) granted Orphan Drug designation to the company’s flagship candidate, JUV-161. JUV-161 is an investigational...
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SHANGHAI, China — JW Therapeutics, an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China accepted the supplemental Biological License Application (sBLA) for its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva® (relmacabtagene...
NESS ZIONA, Israel – Kadimastem Ltd. (TASE: KDST), a clinical stage cell therapy company, announced that it has been granted a patent by The Israel Patent Office for its differentiated human astrocytes from human pluripotent stem cells for use in the treatment and drug screening of Amyotrophic Lateral Sclerosis (ALS). Specifically, the patent allows...
JERUSALEM and HOUSTON – KAHR, a clinical-stage cancer immunotherapy company developing novel bi-functional fusion proteins, and Cancer Focus Fund, LP, a unique venture capital fund established in collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) to provide funding and clinical expertise to advance promising cancer therapies, today announced that Cancer...
LOS ANGELES, Calif. — Kairos Pharma, Ltd., a clinical stage biopharmaceutical company developing cancer therapeutics designed to reverse cancer drug resistance and immune suppression, announces the dosing of its first patient in its Phase 2 trial testing a combination therapy for its lead therapeutic candidate ENV105 in combination with apalutamide...
BALTIMORE, Maryland — Kallisio, focused on developing solutions to manage toxicity in cancer care, announces FDA 510(k) clearance for Stentra, an individually tailored 3D printed oral stent solution designed to protect healthy tissue in Head and Neck Cancer (HNC) patients. Customized for each patient, the Stentra oral immobilization stent effectively...
FRAMINGHAM, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing approval for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adults...
CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY...
CAMBRIDGE, Mass. & SALISBURY, England — KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents...
CAMBRIDGE, Mass. & SALISBURY, England – KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, announced today that Nancy Stuart has been appointed to its Board of Directors effective March 18, 2021. Ms. Stuart is Chief Operating...