KING OF PRUSSIA, Penn. — Global biotechnology leader CSL today announced the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for garadacimab (CSL312) as a once-monthly prophylactic treatment for hereditary angioedema (HAE). The company also announced the European Medicines Agency (EMA) has accepted the...
treatment News
SEATTLE – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that it has completed a rolling New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (“FDA”) seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI had previously announced the...
CAMBRIDGE, Mass. — Cullinan Oncology, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on modality-agnostic targeted oncology therapies, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLN-619 in relapsed/refractory multiple myeloma. CLN-619 is a potential first-in-class humanized IgG1 monoclonal antibody that...
BOSTON – CureLab Oncology, a clinical-stage biotech company, has been granted a US patent for the application of its lead product for the treatment of ALS, Alzheimer’s, Huntington’s, and Parkinson’s disease. These patent applications were already granted in Asia and Europe. Today, 5 million Americans suffer from Alzheimer’s, 1 million from Parkinson’s, 30,000...
BOSTON, Mass. – CureLab Oncology, a clinical-stage, pre-IPO biotech company, announced that its novel biological agent, Elenagen, has been shown to significantly enhance standard chemotherapy and provides clinical benefits for the patients with the deadliest form ovarian cancer. Elenagen belongs to a novel class of biological agents, supercoiled circular DNA...
PALO ALTO, Calif. — Curio Bioscience today announced the commercialization of the world’s first technology that spatially contextualizes single-cell sequencing data, leveraging a breakthrough invention called Slide-tags developed by the Broad Institute of MIT and Harvard and published in Nature this past December. The first stage of Curio’s commercialization of...
DAEJEON, South Korea — Curocell, South Korea based CAR-T specialized company (CEO: Gunsoo Kim), has completed Phase 2 clinical trial for its next-generation CD19 CAR-T therapy “Anbal-cel” that targets relapsed or refractory DLBCL (Diffuse Large B-cell Lymphoma). This announcement is a significant milestone and is paving the way towards the launch...
BOSTON, Mass. — Cycle Pharmaceuticals Limited (Cycle) announces the launch of ORMALVI (dichlorphenamide) tablets, as a treatment option for patients with hyperkalemic periodic paralysis (HyperPP), hypokalemic periodic paralysis (HypoPP) and related variants, after the approval by the US Food and Drug Administration (FDA).1 PPP is thought to affect about 5,000...
GAINESVILLE, Fla. — Cyclo Therapeutics, Inc. (Nasdaq: CYTH), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today announced that the Company received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) regarding Cyclo...
GAINESVILLE, Fla. – Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families suffering from diseases, today announced that it has posted its protocol on www.ClinicalTrials.gov and is preparing to commence its pivotal Phase 3...