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Oncology

Janssen’s Breakthrough Multiple Myeloma Drug Receives FDA Approval

HORSHAM, PA, November 16, 2015 – Janssen Biotech, Inc., a Janssen Pharmaceutical Company of Johnson & Johnson, announced today the U.S. Food and Drug Administration (FDA) has approved DARZALEX® (daratumumab) injection for intravenous infusion for the treatment of patients with multiple myeloma who have received at least three prior lines …

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Castle Biosciences’ Gene Expression Profile Test Effective at Predicting Metastatic Risk in Eye Cancer Patients

FRIENDSWOOD, Texas–(BUSINESS WIRE)–Castle Biosciences, Inc., a provider of molecular diagnostics to improve cancer treatment decisions, today announced new study results of the Company’s DecisionDx-UM gene expression profile test, verifying that the assay is highly effective at identifying uveal melanoma tumors at high risk of metastasis. The results also confirmed the …

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FDA Grants Accelerated Approval for AstraZeneca’s Lung Cancer Drug

Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after …

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AbbVie Submits Imbruvica Phase 3 Combination Data to FDA

NORTH CHICAGO, Ill., Nov. 13, 2015 /PRNewswire/ — AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for labeling considerations based on safety and efficacy results from the Phase III HELIOS (CLL3001) trial investigating …

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Exact Imaging Introduces Prostate Risk Identification Protocol

BARCELONA, Spain and TORONTO, Nov. 12, 2015 /CNW/ – Exact Imaging (www.exactimaging.com), the world’s leader in high–resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance of the prostate, today introduces PRI-MUS™, the first Prostate Risk Identification Protocol using Micro-Ultrasound. This new protocol, the first of its kind in prostate ultrasound, aims …

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FDA Approves Cotellic as part of a Combination Treatment for Skin Cancer

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved Cotellic™ (cobimetinib) for the treatment of people with BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma in combination with Zelboraf ®(vemurafenib). Cotellic and Zelboraf are not …

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Morphotek Enters License Agreement with Blaze Bioscience for Novel Oncology Imaging Technology

EXTON, Pa., Nov. 9, 2015 /PRNewswire/ — Morphotek®, Inc., a subsidiary of Eisai Inc., announced today that it has entered into a license agreement with Blaze Bioscience, Inc. of Seattle, WA, a privately held biotechnology company developing Tumor Paint technology.  Under the agreement, Morphotek provides to Blaze an exclusive, worldwide, royalty-bearing …

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Liquid Biopsy Promotes Precision Medicine by Tracking Patient’s Cancer

PHOENIX, Ariz. — Nov. 4, 2015 — A team of researchers, including scientists from the Translational Genomics Research Institute (TGen), has reported that analyzing circulating tumor DNA (ctDNA) can track how a patient’s cancer evolves and responds to treatment. In a study published today in Nature Communications, Dr. Muhammed Murtaza …

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