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Genentech’s flu medication Xofluza won a new indication for the treatment of acute, uncomplicated influenza in people 12 years of age and older who have been symptomatic for less than 48 hours and are at high risk of flu-related complications.
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A competitor, Invitae Corporation, presented a poster at the American Society of Human Genetics (ASHG) annual meeting that essentially accuses 23andMe’s tests of completing missing a cancer-causing DNA variant in some ethnic groups.
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Novan Further Expands its Proprietary Nitric Oxide Platform
10/18/2019
Novan, Inc. ("the Company" or "Novan") (Nasdaq:NOVN) today announced that the Company has submitted a request for a pre-IND meeting with the U.S. Food and Drug Administration (FDA) for new product candidate, SB207
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Cyclo Therapeutics Announces Its Support for The Firefly Fund’s Newborn Screening Program
10/18/2019
Cyclo Therapeutics, Inc. (OTCQB:CTDH), formerly CTD Holdings, Inc., a biotechnology company that develops cyclodextrin-based products for the treatment of disease, today announced that the company has provided a grant to The Firefly Fund in support of its newborn screening program for Niemann-Pick Disease Type C.
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FDA Clears ORTHO™ Sera ID-MTS for Use on the ORTHO VISION® Analyzer
10/18/2019
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that ORTHO™ Sera, a suite of extended antigen phenotyping, has been cleared by the U.S. Food and Drug Administration for use on the ORTHO VISION® Analyzer.
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Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
10/18/2019
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) approved Amgen's Supplemental Biologics License Application (sBLA) for Nplate® (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet responses in adults with immune thrombocytopenia (ITP), a rare, serious autoimmune disease characterized by low platelet counts.
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Merck Receives Positive EU CHMP Opinion for Two New Regimens of KEYTRUDA® (pembrolizumab) as First-Line Treatment for Metastatic or Unresectable Recurrent Head and Neck Squamous Cell Carcinoma
10/18/2019
Opinion Supports Use of KEYTRUDA, as Monotherapy or in Combination with Platinum and 5-Fluorouracil Chemotherapy, in Patients Whose Tumors Express PD-L (CPS ≥1)
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Aravive Announces Publication of AVB-500 Nonclinical Study in Treatment-Resistant ccRCC Animal Models in Cancer Research
10/18/2019
Aravive, Inc. (Nasdaq: ARAV), a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis, today announced publication of data from a nonclinical study of AVB-500, the company’s lead product candidate, which demonstrated reduction in tumor size and blood vessel density in animal models of clear cell renal cell carcinoma (ccRCC).
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Nuvectra Submits Chemical Composition and Biocompatibility Data to FDA for Virtis™
10/18/2019
Nuvectra Corporation (NASDAQ: NVTR), a neurostimulation medical device company, today announced it has submitted supplementary chemical composition and biocompatibility data to the U.S. Food and Drug Administration (FDA) in support of the Company’s Virtis pre-market approval (PMA) application for the treatment of chronic urinary retention and symptoms of overactive bladder.
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Arrowhead Pharmaceuticals Hosts R&D Day on Emerging Pipeline of RNAi Therapeutics
10/18/2019
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) is hosting a Research & Development (R&D) Day today in New York to discuss its emerging pipeline of RNAi therapeutics that leverage its proprietary Targeted RNAi Molecule Platform (TRiM™) platform.
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Potential for Fundamental Change in the Treatment of Brain Cancer
10/18/2019
Noxopharm (ASX: NOX) announces that it will apply its glutamate-inhibition technology to the treatment of glioblastoma multiforme (GBM).
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Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Eligible Infants with Cystic Fibrosis as Early as 6 Months of Age
10/18/2019
Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor), to include use in infants with cystic fibrosis (CF) ages 6 months to less than 12 months who have one of the following mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
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Centene and WellCare Announce Five Additional State Insurance Department Approvals for Pending Merger
10/18/2019
Centene Corporation and WellCare Health Plans, Inc. announced that the insurance departments of Arizona, Connecticut, Georgia, Ohio and Texas have now also approved Centene's pending acquisition of WellCare, bringing the total number of states to approve the transaction to 24..
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Rigel Receives Positive Trend Vote from CHMP for Fostamatinib Disodium Hexahydrate for Adult Patients with Chronic Immune Thrombocytopenia (ITP) in Europe
10/18/2019
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive trend vote on the Marketing Authorization Application (MAA) for fostamatinib disodium hexahydrate (fostamatinib)
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AbbVie Receives CHMP Positive Opinion for Upadacitinib (RINVOQ™) for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis
10/18/2019
AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for RINVOQ™ (upadacitinib), a once-daily selective and reversible JAK inhibitor
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United Health Products Announces Positive Results from HemoStyp® Human Clinical Trial
10/18/2019
United Health Products, Inc. announced that it has received the final report from an independent review of the results of its human clinical trial.
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Cipher Pharmaceuticals Receives Health Canada Approval For Trulance® (Plecanatide)
10/18/2019
Cipher Pharmaceuticals Inc. announced it has received Health Canada approval, on October 10, 2019, for TRULANCE®, a Guanylate cyclase-C agonist in the form of a once-daily tablet for the treatment of adults with irritable bowel syndrome with constipation.
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Verrica Pharmaceuticals Announces Presentation of Positive Data from Clinical Trials of VP-102 at the 2019 39th Annual Fall Clinical Dermatology Conference
10/18/2019
Pooled analyses of the Phase 3 CAMP studies in molluscum contagiosum showed VP-102 achieved statistically significantly higher rate of complete lesion clearance and percentage of subjects with > 75% and > 90% lesion clearance rates over the course of therapy compared to vehicle
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Arena Pharmaceuticals' Presence at United European Gastroenterology Week Bolsters Commitment to the Gastrointestinal Disease Community
10/18/2019
Arena Pharmaceuticals, Inc. will present new open-label extension data from the Phase 2 OASIS trial for its investigative drug candidate etrasimod, a next-generation, once-daily, oral, selective sphingosine 1-phosphate receptor modulator, in patients with moderately to severely active ulcerative colitis at the 25th Annual United European Gastroenterology Week.
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Isofol Receives Positive Feedback From PMDA in Japan, Expanding Ongoing Global Pivotal Phase 3 AGENT Trial in First Line Metastatic Colorectal Cancer
10/18/2019
Isofol Medical AB, announced the successful completion of Japan's Pharmaceutical and Medical Devices Agency review of the Clinical Trial Notification, allowing the start of the pivotal Phase 3 AGENT clinical study in metastatic colorectal cancer at Japanese sites.