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 The leading web portal for pharmacy resources, news, education and careers March 30, 2015
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - March 30, 2015

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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3/24/15 - Critical Diagnostics Presage ST2 Assay Cardiac Biomarker Test Receives China Food and Drug Administration Clearance
Critical Diagnostics announced today that the China Food and Drug Administration has cleared the Presage ST2 Assay for clinical use. In March 2012 Critical Diagnostics appointed Everbest International as its exclusive distributor for the Presage ST2 Assay in the People's Republic of China, Taiwan, Hong Kong and Macau. Since then Critical Diagnostic
3/24/15 - FDA Approvals & Expanded Distribution: The Bigger Picture For Supplementation
For companies like Axxess Pharma, Totally Hemp Crazy, Inc., and Electronics Cigarettes International Group. In fact, when it comes to supplement companies, Axxess Pharma has seen significant progress this year. Daniel Bagi, President of Axxess Pharma, Inc. stated: "We are very excited to receive FDA approval to sell our latest line of all-natural T
3/24/15 - Flow-Fx announces Flow-Screw 510K clearance
Mokena, Ill., Mar. 24, 2015/ PRNewswire-iReach/ Flow-FX LLC announced today that the FDA has allowed 510 K clearance for its Flow-Screw product family. Flow-Screw is the second product family cleared by the FDA as the Flow-Nail was cleared in July, 2014. Its patented screw/cannula system enables precision delivery of bone void filler through a ca
3/23/15 - Abiomed Impella 2.5 Receives FDA Approval for Elective and Urgent High Risk Percutaneous Coronary Intervention (PCI) Procedures
Abiomed, Inc., a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration Pre-Market Approval for the Impella 2.5 heart pump during elective and urgent high risk percutaneous coronary intervention procedures. This approval is based on the extensive clinical data submitt
3/23/15 - Actavis Receives FDA Approval of SAPHRIS for Pediatric Patients age 10-17 for Acute Treatment of Manic or Mixed Episodes of Bipolar I Disorder
By a News Reporter-Staff News Editor at Pharma Business Week Actavis plc announced that the U.S. Food and Drug Administration has approved its supplemental new drug application for SAPHRIS as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients. "We were pleased to see that SAPHR
3/23/15 - New ASBM Survey Provides Physicians' Views on Biosimilar Labeling
The Alliance for Safe Biologic Medicines today released the results from a survey on physicians' priorities related to biosimilar labeling. His presentation addressed the recent approval of the first biosimilar medicine in the U.S. and the timeliness of the new survey data as FDA considers the multiple biosimilar applications said to be pending b
3/23/15 - Rep. Stivers Introduces Bill to Speed Up Review of Pharmaceuticals Approved for Marketing in European Union
by AILE DAYANDANTE Targeted News Service. Steve Stivers, R- Ohio, has introduced legislation to "require the Food and Drug Administration to expedite review of pharmaceuticals that are approved for marketing in the European Union." Myron Struck, editor, Targeted News Service, Springfield, Va., 703/ 304-1897;;...
3/23/15 - Ross Medical Technology Receives FDA 510(K) Clearance for ECG Monitoring Platform to Help Replace Traditional Hospital Admissions
New Control Center Platform and Device Offers Continuous Real-Time ECG Monitoring and Cardiac Event Detection for Patients Receiving a Hospital-Like Workup in the Community. SADDLE RIVER, NJ/ ACCESSWIRE/ March 23, 2015/ Ross Medical Technology, Inc. is pleased to announce that its newest medical device and related system, CardiacLinx, has received
3/23/15 - Therapure Innovations Receives FDA Approval to Proceed with a Phase 1 Clinical Trial of Its Novel Anemia Therapeutic TBI 304H
By a News Reporter-Staff News Editor at Clinical Trials Week Therapure Innovations, a division of Therapure Biopharma Inc., announces that the U.S. Food and Drug Administration has given the Company approval to proceed with a Phase 1 clinical trial of TBI 304 H for the treatment of chemotherapy-induced anemia. "This product candidate presents a
3/23/15 - TomTec receives FDA 510k clearance for its latest version of TomTec-Arena software
By a News Reporter-Staff News Editor at Pharma Business Week TomTec Imaging Systems GmbH announces the FDA 510 clearance for its innovative TomTec-ArenaTM software solution. TomTec-Arena is a suite of clinical applications to review, analyze and quantify medical image data in multiple dimensions and multiple modalities such as Ultrasound, XA, MR
3/23/15 - ZONARE Features Z.One PRO and ZS3 Ultrasound Systems at American Institute of Ultrasound in Medicine
ZONARE, a developer of next generation ultrasound technology, is featuring its Z.One PRO and ZS3 ultrasound systems at the annual American Institute of Ultrasound in Medicine meeting being held in Orlando March 22 25, 2015. The company also is introducing the new C9-3sp intra-operative curved array transducer, which recently received FDA 510 k c
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