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Newly Published Study Shows DecisionDx-Melanoma Prognostic Test Accurately Identified Risk for Patients with Melanoma of the Head and Neck

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a skin cancer diagnostics company providing personalized genomic information to improve cancer management decisions, today announced the publication of a study highlighting the ability of the DecisionDx®-Melanoma test to accurately determine risk of metastasis in patients with melanoma of the head and neck. Results from …

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Xencor and Genentech Partner to Develop and Commercialize Novel IL-15 Immune Activating Cytokines

MONROVIA, Calif., Feb. 5, 2019 /PRNewswire/ — Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease, and cancer, today announced it has entered into a research and license agreement with Genentech, a member of the Roche Group, to develop and commercialize novel …

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RDx BioScience Genetic Risk Testing Identifies Harmful Mutation in BRCA1 or BRCA2 Human Genes Indicating Higher Likelihood of Breast Cancer

KENILWORTH, N.J.–(BUSINESS WIRE)–RDx BioScience (RDx) calls for increased use of genetic testing to identify mutations in BRCA1 and BRCA2, the genes discovered in the 1990s to be strongly associated with a high risk of breast cancer. RDX, a single source for care quality, risk evaluation and opioid expertise powered by a fast, full-service laboratory, raises awareness …

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Sanofi’s Isatuximab Meets Primary Endpoint of Prolonging Progression Free Survival in Phase 3 Multiple Myeloma Trial

PARIS – February 5, 2019 – The pivotal Phase 3 trial of isatuximab in patients with relapsed/refractory multiple myeloma met the primary endpoint of prolonging progression free survival in patients treated with isatuximab in combination with pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone alone (standard of care). Results …

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FDA Grants Priority Review to Daiichi Sankyo’s CSF1R Inhibitor for Treatment of Patients with Tenosynovial Giant Cell Tumor

TOKYO and MUNICH and BASKING RIDGE, N.J., Feb. 5, 2019 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for pexidartinib for the treatment of adult patients with symptomatic tenosynovial …

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Merck KGaA and GSK Partner to Jointly Develop and Commercialize Novel Immunotherapy with Potential in Multiple Difficult-to-Treat Cancers

DARMSTADT, Germany, Feb. 5, 2019 /PRNewswire/ — Merck KGaA, Darmstadt, Germany, a leading science and technology company and GSK, a science-led global healthcare company, today announced that the companies have entered into a global strategic alliance to jointly develop and commercialize M7824 (bintrafusp alfa*). M7824 is an investigational bifunctional fusion …

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Genentech Submits sBLA to FDA for Kadcyla for Adjuvant Treatment in HER2-Positive Early Breast Cancer with Residual Disease After Neoadjuvant Treatment

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced completing the submission of a supplemental Biologics License Application to the U.S. Food and Drug Administration (FDA) for Kadcyla® (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer …

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FDA Grants Orphan Drug Designation to BioLineRx’s Lead Candidate BL-8040 for the Treatment of Pancreatic Cancer

Tel Aviv, Israel, February 4, 2019 – BioLineRx Ltd. (NASDAQ/TASE:BLRX), a clinical-stage biopharmaceutical company focused on oncology, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of pancreatic cancer.  “Orphan Drug Designation in pancreatic cancer …

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OPKO Health Receives FDA Approval for the Point-of-Care Sangia PSA Test with the Claros 1 Analyzer

MIAMI, Feb. 01, 2019 (GLOBE NEWSWIRE) — OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s point-of-care Sangia Total Prostate Specific Antigen (PSA) Test using the Claros 1 Analyzer.  The product is indicated to quantitatively measure total PSA in whole blood from a …

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OncoSec Provides KEYNOTE-695 Clinical Update And Outlines 2019 Milestones

SAN DIEGO and PENNINGTON, N.J., Feb. 1, 2019 /PRNewswire/ — OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, provided a clinical data update today regarding KEYNOTE-695, as well as progress of its ongoing clinical development efforts and its outlook for 2019. KEYNOTE-695 (TAVO™ + KEYTRUDA® (pembrolizumab) for metastatic/recurrent melanoma) With one …

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