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Tag Archives: FDA

Apollo Endosurgery Provides Update and Clarity to FDA Letter to Health Care Providers Related to Potential Risks of Intragastric Balloons

Friday, August 11th 2017 at 3:29am UTC Conference Call Scheduled for Friday, August 11, 2017 at 8:30 AM (EDT) to Discuss Letter AUSTIN, Texas–(BUSINESS WIRE)– Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a leader in less invasive medical devices for bariatric and gastrointestinal procedures, today provided an update and clarifications to a …

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Dicerna Reports Second Quarter 2017 Financial and Operating Results and Provides Corporate Update

Thursday, August 10th 2017 at 8:05pm UTC Management to Host Conference Call Today at 4:30 p.m. ET CAMBRIDGE, Mass.–(BUSINESS WIRE)– Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today reported financial and operating results for the second quarter ended June 30, 2017. “We are …

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La FDA permite a WIN Consortium seguir con el ensayo clínico de terapia triple en el tratamiento en primera línea del cáncer pulmonar metastásico de células no pequeñas

Wednesday, August 9th 2017 at 12:43pm UTC VILLEJUIF, Francia–(BUSINESS WIRE)– WIN Consortium (WIN) recibió la aprobación de la FDA, organismo para el control de alimentos y medicamentos, para empezar con la investigación clínica de un nuevo enfoque terapéutico que usa una combinación de tres terapias específicas para el tratamiento en …

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La FDA approuve l’essai clinique du Consortium WIN de trithérapie ciblée en première ligne de traitement du cancer métastatique du poumon non à petites cellules

Wednesday, August 9th 2017 at 10:00am UTC VILLEJUIF, France–(BUSINESS WIRE)– Le Consortium WIN (WIN) a reçu l’approbation de la Food and Drug Administration (FDA) américaine pour le lancement de la recherche clinique en vue d’une nouvelle approche thérapeutique utilisant une combinaison de trois thérapies ciblées pour le traitement en première …

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Pebble Labs Builds Science Team with Four Research Hires

Wednesday, August 9th 2017 at 3:48pm UTC Team Joins Dr. Richard Sayre in Developing Breakthrough Biotechnology to Block Zika, Dengue from Being Transmitted by Mosquitoes LOS ALAMOS, N.M.–(BUSINESS WIRE)– Pebble Labs Inc., the biotechnology company developing biologically engineered solutions to eliminate the transmission of mosquito-carried diseases including Zika and Dengue, …

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100th Patient Enrolled in Clinical Trials for Active Implants’ NUsurface® Meniscus Implant

Wednesday, August 9th 2017 at 1:00pm UTC Implant Being Investigated as First “Artificial Meniscus” MEMPHIS, Tenn.–(BUSINESS WIRE)– Active Implants, LLC, a company that develops orthopedic implant solutions, today announced enrollment of the 100th patient in clinical trials evaluating the NUsurface® Meniscus Implant for the treatment of persistent knee pain caused …

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Gilead Announces U.S. FDA Priority Review Designation for Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV

Thursday, August 10th 2017 at 8:01pm UTC — Final FDA Decision Anticipated by February 12, 2018 — FOSTER CITY, Calif.–(BUSINESS WIRE)– Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for an investigational, …

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22nd Century Group Files 2017 Second Quarter Report and Announces Conference Call to Provide Business Update

Wednesday, August 9th 2017 at 8:15pm UTC 22nd Century’s proprietary Very Low Nicotine technology puts the Company at the forefront of “the most important public-health initiative of the century.” Current Cash Balance is the Highest in Company History. CLARENCE, N.Y.–(BUSINESS WIRE)– 22nd Century Group, Inc. (NYSE American: XXII), a plant …

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FDA’s Plan to Lower Nicotine in Cigarettes Has Captured the Attention of Regulators and Public Health Experts Around the World

Wednesday, August 9th 2017 at 5:01pm UTC Officials in Canada, New Zealand and U.K. are Now Pursuing Nicotine Reduction Policies CLARENCE, N.Y.–(BUSINESS WIRE)– 22nd Century Group, Inc. (NYSE American: XXII), a plant biotechnology company that is focused on tobacco harm reduction, announced today that, as reported in Bloomberg News, the …

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CYTOVIA Inc, IMMUNE Pharma’s Oncology Subsidiary, Announces Publication of Results Showing Anti-Metastatic Properties of Its Lead Drug Ceplene® and Filing of a New Worldwide Patent

Wednesday, August 9th 2017 at 1:30pm UTC Additional potential in cancer immunotherapy with Ceplene in combination with Interleukin-15 (IL-15) NEW YORK–(BUSINESS WIRE)– Cytovia, the oncology subsidiary of Immune Pharmaceuticals Inc. (NASDAQ:IMNP) (« Immune »), a clinical stage biopharmaceutical company, today announced the publication of results showing favorable effects of its lead immunotherapeutic …

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