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Tag Archives: FDA

Novaliq GmbH Announces Licensing Agreement with AFT Pharmaceuticals for the Distribution of NovaTears®

Monday, March 20th 2017 at 7:45pm UTC NovaTears®, A Novel Treatment for Dry Eye Disease, Is Now Available in Australia and New Zealand HEIDELBERG, Germany–(BUSINESS WIRE)– Novaliq, a specialty pharmaceutical company with a disruptive drug delivery platform that transforms poorly soluble drugs into effective therapeutics for ophthalmology, today announced a …

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Cerulean and Daré to Host Conference Call on Proposed Transaction on March 23

Tuesday, March 21st 2017 at 1:38am UTC CAMBRIDGE, Mass.–(BUSINESS WIRE)– Cerulean Pharma Inc. (NASDAQ:CERU), today announced jointly with Daré Bioscience that the companies will hold a joint conference call to discuss the definitive share purchase agreement under which the stockholders of Daré Bioscience will become the majority owners of Cerulean. …

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ZOLL Receives Health Canada Approval for Two New Models Of AEDS

Tuesday, March 21st 2017 at 5:03pm UTC Expands Lifesaving Portfolio with Enhanced Real CPR Help and Program Management Onboard CHELMSFORD, Mass.–(BUSINESS WIRE)– ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, announced today that Health Canada has approved the ZOLL AED 3™* and …

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Variantyx Launches Genomic Intelligence® Clinical Diagnostic Platform

Tuesday, March 21st 2017 at 1:00pm UTC FRAMINGHAM, Mass.–(BUSINESS WIRE)– Variantyx announced the US launch of its proprietary clinical diagnostic platform at the American College of Medical Genetics (ACMG) conference in Phoenix, AZ. The Genomic Intelligence® platform automates the complete NGS testing process from sample collection to sequencing, data analysis, …

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NantKwest Announces FDA Grant of Orphan Drug Designation for the Company’s aNK Natural Killer Cell Therapy in Merkel Cell Carcinoma

Monday, March 20th 2017 at 11:00am UTC CULVER CITY, Calif.–(BUSINESS WIRE)– NantKwest, Inc. (Nasdaq:NK), a pioneering, next generation, clinical-stage immunotherapy company focused on harnessing the unique power of our immune system using natural killer (NK) cells to treat cancer, infectious diseases and inflammatory diseases, announced today that the FDA has …

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Bristol-Myers Squibb and CytomX Therapeutics Extend Worldwide Collaboration to Discover Probody™ Therapeutics for the Treatment of Cancer and Other Diseases

Monday, March 20th 2017 at 10:59am UTC Builds upon initial 2014 alliance in oncology Includes up to eight additional targets in oncology and other therapeutic areas CytomX to receive $200 million upfront payment NEW YORK & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)– Bristol-Myers Squibb Company (NYSE:BMY) and CytomX Therapeutics, Inc. (Nasdaq:CTMX), …

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Novaliq GmbH annonce un contrat de licence avec AFT Pharmaceuticals pour la distribution de NovaTears®

Monday, March 20th 2017 at 11:54pm UTC NovaTears®, un nouveau traitement contre la sécheresse oculaire, est désormais disponible en Australie et en Nouvelle-Zélande HEIDELBERG, Allemagne–(BUSINESS WIRE)– Novaliq, une société pharmaceutique spécialisée qui possède une plateforme d’administration de médicaments d’avant-garde, transformant des médicaments peu solubles en produits ophtalmologiques efficaces, a annoncé …

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Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vascular Access for Hemodialysis

Monday, March 20th 2017 at 3:00pm UTC RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that …

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InVivo Therapeutics Announces Submission to the FDA of Its Nonclinical Studies Module for the Neuro-Spinal Scaffold™

Tuesday, March 21st 2017 at 12:00pm UTC – First of Three Modules to be Submitted for Product Approval – CAMBRIDGE, Mass.–(BUSINESS WIRE)– InVivo Therapeutics Holdings Corp. (NVIV) today announced that it has submitted its first module containing nonclinical studies to the U.S. Food and Drug Administration (FDA) as part of its …

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Asana BioSciences Announces FDA Acceptance of the IND Application for its Novel SYK-JAK Inhibitor for Evaluation in Atopic Dermatitis

Thursday, March 16th 2017 at 2:29pm UTC LAWRENCEVILLE, N.J.–(BUSINESS WIRE)– Asana BioSciences, LLC, a clinical stage biopharmaceutical company, today announced that the FDA has accepted the IND application for ASN002, a novel dual SYK-JAK inhibitor, for atopic dermatitis. The Phase I randomized, double-blind, placebo-controlled, multiple dose escalation study will evaluate …

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