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432 Result: FDA

Auris Medical Reports Key Results from Keyzilen(R) AMPACT2 Open-Label Extension Study

April 24th, 2017

* Trial outcomes show positive safety profile of Keyzilen® for chronic intermittent use * Exploratory efficacy results support therapeutic concept of early tinnitus treatment Zug, Switzerland / CRWE PRESS RELEASE / April 24, 2017 - Auris Medi. Read more

CorMedix Inc. Reports Update on Neutrolin(R) Phase 3 LOCK-IT 100 Clinical Trial

April 20th, 2017

Bedminster, NJ / CRWE PRESS RELEASE / April 20, 2017 - CorMedix Inc. (NYSE MKT: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease,. Read more

Diplomat Will Dispense ZEJULA(TM) to Treat Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

April 19th, 2017

The nation’s largest independent specialty pharmacy has been selected to the specialty pharmacy panel to dispense ZEJULA™ (niraparib). FLINT, Mich. / CRWE PRESS RELEASE / April 19, 2017 – Diplomat Pharmacy, Inc. (NYSE: DPLO), ha. Read more

Puma Biotechnology Announces FDA Advisory Committee to Review Neratinib for the Extended Adjuvant Treatment of HER2-Positive Early Stage Breast Cancer

April 17th, 2017

LOS ANGELES, Calif. / CRWE PRESS RELEASE / April 17, 2017 - Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for n. Read more

AVEO Announces Submission of Response to Tivozanib Marketing Authorization Application Day 180 List of Outstanding Issues

April 13th, 2017

CAMBRIDGE, Mass. / CRWE PRESS RELEASE / April 13, 2017 - AVEO Oncology (NASDAQ: AVEO) today announced that its European licensee for tivozanib, EUSA Pharma, has submitted responses to the European Medicines Agency (EMA) Day 180 List of Outstanding Is. Read more

Ritter Pharmaceuticals, Inc. Announces End of Phase 2 Meeting with the FDA and Initiates Phase 3 Program Development Activities

April 12th, 2017

Los Angeles, California / CRWE PRESS RELEASE / April 12, 2017 - Ritter Pharmaceuticals, Inc. (NASDAQ: RTTR) (the “Company”) today, April 12, 2017, announced that the U.S. Food and Drug Administration (FDA) has agreed to schedule an end of. Read more

Alere Achieves FDA Clearance for Alere(TM) Reader Platform and Alere BinaxNOW(R) Influenza A & B Card 2

April 11th, 2017

WALTHAM, Mass. / CRWE PRESS RELEASE / April 11, 2017 - Alere Inc. (NYSE: ALR), a global leader in rapid diagnostics, today announced that its Alere™ Reader, a diagnostic analyzer that can be used in both point-of-care and laboratory settings, h. Read more

Puma Biotechnology Launches Expanded Access Program for PB272 (Neratinib) for U.S. Patients with HER2-Positive Breast Cancer or HER2-Mutated Cancer

April 02nd, 2017

Caligor Opco LLC to Provide Regulatory and Logistical Management LOS ANGELES, Calif. / CRWE PRESS RELEASE / April 2, 2017 - Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, has initiated an expanded access program (EAP) in the. Read more

miRagen Therapeutics Provides Corporate Update

March 31st, 2017

BOULDER, CO / CRWE PRESS RELEASE / March 31, 2017 - miRagen Therapeutics, Inc. (Nasdaq: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA-targeted therapies, today reported recent clinical and fina. Read more

Corindus Announces First Robotic-Assisted PCI Procedures Performed in Asia Using CorPath(R) GRX System

March 31st, 2017

Live Case Transmitted from Fu Wai Hospital to China Interventional Therapeutics Conference in Beijing Waltham, MA / CRWE PRESS RELEASE / March 31, 2017 - Corindus Vascular Robotics, Inc. (NYSE MKT: CVRS), a leading developer of precision vascular . Read more

miRagen Therapeutics Receives Orphan-Drug Designation for MRG-106 for the Treatment of Mycosis Fungoides

March 31st, 2017

BOULDER, CO / CRWE PRESS RELEASE / March 31, 2017 - miRagen Therapeutics, Inc. (Nasdaq: MGEN), a clinical-stage biopharmaceutical company focused on the discovery and development of microRNA-targeted therapies, today announced that the U.S. Food. Read more

Ritter Pharmaceuticals Announces Lactose Intolerance Treatment, RP-G28, Demonstrated Efficacy and Clinically Meaningful Benefit in Phase 2b/3 Clinical Trial

March 28th, 2017

Los Angeles, California / CRWE PRESS RELEASE / March 28, 2017 – Ritter Pharmaceuticals, Inc. (NASDAQ:RTTR) (the “Company”) today announced topline findings from its Phase 2b/3 study designed to evaluate RP-G28 in subjects with lacto. Read more

FDA approves drug to treat Parkinson's disease

March 21st, 2017

Silver Spring, MD / CRWE PRESS RELEASE / March 21, 2017 - The U.S. Food and Drug Administration today approved Xadago (safinamide) tablets as an add-on treatment for patients with Parkinson’s disease who are currently taking levodopa/carbidopa . Read more

Kitov Announces License Agreement for KIT-302 in South Korea

March 08th, 2017

Definitive agreement grants Kuhnil Pharmaceutical Co. Ltd. an exclusive license to manufacture and market KIT-302 in South Korea Transaction is Kitov's First License Agreement for KIT-302 Celecoxib is the leading NSAID product in South Kore. Read more

ASPiRA LABs Announces Provider Status with Medi-Cal Expanding OVA1(R) Access to Over 12 Million Beneficiaries

March 06th, 2017

AUSTIN, Texas / CRWE PRESS RELEASE / March 6, 2017 — ASPiRA LABs, a Vermillion company (NASDAQ: VRML), today announced it has attained out-of-state provider status with Medi-Cal, California’s Medicaid program, for OVA1®/Multivari. Read more

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