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Statement from FDA Commissioner Scott Gottlieb, M.D., on implementation of agency's streamlined development and review pathway for consumer tests that evaluate genetic health risks
11/7/2017
In its consideration of GHR tests, the FDA seeks to strike a balance that provides for an efficient pathway to bring these tests to consumers, without sacrificing the assurances offered by FDA oversight.
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DNAe to Present New Data on LiDia BSI, its Rapid Blood-to-Result Diagnostic Test at the Association of Molecular Pathology Annual Meeting
11/7/2017
DNAe will be presenting new data at the AMP Annual Meeting 2017 in Salt Lake City, USA from the 16th to 18th November.
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Amgen Announces New Analyses of High-Risk Patient Subgroups From Repatha (evolocumab) Cardiovascular Outcomes Study at AHA Scientific Sessions 2017
11/7/2017
Results will be presented at the AHA Scientific Sessions 2017 in Anaheim, Calif., Nov. 11-15.
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Lycera Presents Tumor Selection Rationale for Phase IIa Study at SITC's 2017 Annual Meeting for RORgamma Agonist, LYC-55716
11/7/2017
Lycera has selected multiple tumor types, including non-small-cell lung cancer, squamous cell head and neck cancer, ovarian cancer, urothelial cancer, renal cell cancer, and esophageal / gastric cancer for inclusion in the Phase IIa portion of the ARGON study.
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Akriveia Therapeutics' Aklusion Platform for Tumor-Targeting Cancer Immunotherapies to be Featured in Poster Presentation at the Society for Immunotherapy of Cancer's (SITC) 32nd Annual Meeting
11/7/2017
The poster's authors include scientists from the laboratories of Professor John Williams of the Beckman Research Institute at the City of Hope and Professor Ulrich Rodeck at Thomas Jefferson University, along with Dr. Margaret Karow, Senior Vice President of Drug Discovery and Preclinical Development at Akriveia Therapeutics.
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GSK Presents New Data at ACR for BENLYSTA (belimumab) for Subcutaneous Use (SC), Showing Reduced Need to Increase Corticosteroid Dose
11/7/2017
The data being presented at the 2017 ACR/AHRP) show that weekly treatment with BENLYSTA SC 200mg reduced the need to increase the dose of corticosteroid (one standard of care medication for patients with SLE).
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BioIVT to Present Advances in Immunohistochemistry at AAPS Annual Meeting
11/7/2017
This conference will be held from Nov. 12-15 at the San Diego Convention Center in San Diego, CA.
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UCB Presents New Findings Advancing Patient Care for Chronic Inflammatory Diseases and Osteoporosis at 2017 ACR/ARHP Annual Meeting
11/7/2017
Study findings suggest that opioids are vastly overprescribed as a treatment for pain associated with AS, often in lieu of more effective treatments such as anti-TNFs and NSAIDs.
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Fraunhofer Life Science Symposium: Latest Developments in the Field of Infection Diagnostics
11/7/2017
The Fraunhofer Life Science Symposium will take place in Leipzig from 8 to 9 November 2017.
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Pique Therapeutics Announces Positive Results in Phase II Clinical Trial of Lead Immunotherapy for Non-Small Cell Lung Cancer
11/7/2017
The Phase II trial was seeking to confirm the safety of PT 107, and further evaluate the efficacy of the drug.
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Nordic Nanovector ASA to Host Capital Markets Day and Present Q3 Results On 22 November 2017 in Oslo
11/7/2017
At the Capital Markets Day, Executive management and selected external speakers will provide insight to the company's strategy, market landscape and opportunities, and status on clinical development plans.
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The company is pulling these particular devices due to the number of complaints that it received relating to partial stent deployment.
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The PE firm made the investment just three years ago.
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The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.
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OPKO Health Submits Premarket Approval Application with FDA for a Point-of-Care PSA Test with the Claros 1 Platform
11/7/2017
The filing contains clinical data from the Company’s 864-patient Total PSA clinical study.
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Axonics Receives IDE Clearance From U.S. FDA to Conduct a Pivotal Study With Its Sacral Neuromodulation System for the Treatment of Urinary Dysfunction
11/7/2017
Axonics announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States.
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Cerus Corporation Receives IDE Approval to Initiate Phase III ReCePI Study
11/7/2017
ReCePI is designed to evaluate the efficacy and safety of INTERCEPT Red Blood Cells (RBCs) in patients requiring transfusion for acute blood loss during surgery.
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FDA Performs Pre-Approval Inspection of Intersect ENT's Menlo Park Facility
11/7/2017
At the conclusion of the inspection, the FDA issued a Form 483 with four inspectional observations.
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NanOlogy Announces First Patient Enrolled in a Phase II Clinical Trial of NanoPac for Treatment of Mucinous Cysts of the Pancreas
11/7/2017
The Phase 2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into MCNs by endoscopic ultrasound-guided fine needle injection.
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Creative Diagnostics Introduces Treponema Pallidum Antigens
11/7/2017
As a leading supplier of research products and custom services to global academic, pharmaceutical and biotech communities, Creative Diagnostics has introduced new treponema pallidum antigens for the diagnosis of syphilis, including recombinant T. Pallidum TpN47, T. Pallidum Major Membrane Immunogen p15 and T.