Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers July 28, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - July 28, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 46     Next >>     Go To Page:

7/28/17 - Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR NECTAR (barium sulfate) Oral Suspension
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration approved VARIBAR NECTAR oral suspension for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and p
7/28/17 - Corporate News Blog - Sensus Healthcare Announces Achievement of Approval from China's FDA for SRT-100, the Non-Invasive Superficial Radiation Therapy
LONDON, UK/ ACCESSWIRE/ July 28, 2017/ Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Sensus Healthcare, Inc., following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/? Sensus operates in China through its partner, Chindex Medical Limited, a
7/28/17 - McDonald's cleared after viral video
By Hu Min| 00:01 UTC +8 July 28, 2017| Print Edition. At a McDonald's outlet on Hechuan Road in Minhang District yesterday, officials with the Shanghai Food and Drug Administration checked the license, food materials, operation procedures and hygiene. In a statement, McDonald's China assured customers that its ice cream machines are clean and safe.
7/27/17 - Agfa HealthCare Receives FDA 510(k) Clearance for Advanced Clinical Applications on XERO Universal Viewer
The XERO Viewer is part of Agfa HealthCare's award-winning Enterprise Imaging platform, which consolidates imaging data from multiple service lines and provides secure access to a patient's medical images, in one view, accessible' anywhere, anytime'. KLAS honored the XERO Viewer with its 2017 Category Leader Award, noting Agfa HealthCare's continuo
7/27/17 - NOVOCURE LTD - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations
We encourage you to read this MD&A in conjunction with our consolidated financial statements and the notes thereto for the period ended June 30, 2017 included in Part I, Item 1 of this Quarterly Report on Form 10- Q. This discussion contains forward-looking statements that involve risks and uncertainties. In October 2015, we received FDA approval t
7/27/17 - Q Therapeutics Approved to Start Trial of Cell Therapy Aiming to Restore Myelin [Syrian Arab News Agency]
A cell therapy intended to boost myelin regeneration Q-Cells by Q Therapeutics has received a green light from the U.S. Food and Drug Administration to proceed with a clinical trial in patients with transverse myelitis (TM), a disease that like multiple sclerosis is characterized by myelin damage. FDA approval of the companys Investigational New Dr
7/27/17 - Quantel Medical Receives FDA Approval for Easyret Photocoagulator Laser
In 1995, Quantel was the first company to introduce solid-state diode-pumped technology for green photocoagulators. In 2016, Quantel introduced a new revolution with fiber laser technology for 577 nm yellow lasers in Europe. Quantel engineers worked closely with surgeons to design a fully integrated system with an intuitive interface to ensure o
7/27/17 - Spectranetics Announces FDA Approval of Stellarex Drug-Coated Balloon [T-break Tech (Middle East)]
-The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration Pre-Market Approval of the Stellarex drug-coated balloon, designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. Sean Lyden, ILLUMENATE Pivotal Trials Co-Principal...
7/27/17 - U.S. FDA Approves Additional Use of Antiepileptic Drug Fycompa as Monotherapy for Partial-Onset Seizures
Eisai issued the following news release:. Eisai Co., Ltd. has announced that on July 26, 2017, its U.S. subsidiary Eisai Inc. received approval from the U.S. Food and Drug Administration for a supplemental New Drug Application for Eisai's antiepileptic drug Fycompa as monotherapy use for the treatment of partial-onset seizures in patients with epil
7/27/17 - U.S. FDA Grants Priority Review for an Epinephrine Auto-Injector in Development by Kalo Specifically for Infants and Small Children
Priority Review designation by the FDA is given to drugs that, if approved, may provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to available therapies. "National Institutes of Health guidelines now recommend that certain infants be evaluated for potentia
7/26/17 - Aspect Imaging Announces FDA Clearance of EmbraceTM; the First Dedicated Neonatal MRI System for the NICU
Aspect Imaging, a developer of compact high-performance MRI systems, has announced today, that it has received Food and Drug Administration clearance for the first neonatal-dedicated MRI system, Embrace TM Neonatal MRI system. Since Embrace TM is specifically designed for neonatal brain and head imaging in the neonatal intensive care unit, the unne
7/26/17 - Celgene Agrees to Pay $280 Million to Resolve Fraud Allegations Related to Promotion of Cancer Drugs Not Approved by FDA
Celgene Corp., a manufacturer of pharmaceuticals headquartered in Summit, New Jersey, has agreed to pay $280 million to settle fraud allegations related to the promotion of two cancer treatment drugs for uses not approved by the Food and Drug Administration, the Justice Department announced today. The lawsuit also alleged that Celgene violated the
7/26/17 - Cut FDA Red Tape So Doctors Can Better Treat Patients
Is an outdated FDA regulation to blame? The FDA prohibits pharmaceutical companies from sharing information about "off-label" uses of medicines with physicians. Many drugs received FDA approval for one disease, but also effectively treat other illnesses that aren't listed on the official label.
7/26/17 - FDA Approves Eisai's FYCOMPA (perampanel) for Use as Monotherapy for the Treatment of Partial-Onset Seizures
Eisai Inc. announced today that the U.S. Food and Drug Administration has approved the company's supplemental New Drug Application for FYCOMPA CIII as monotherapy use for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 12 years of age and older. FYCOMPA is the first AED approve
7/26/17 - Janssen Announces U.S. FDA Approval Of TREMFYA Guselkumab For The Treatment Of Moderate To Severe Plaque Psoriasis
By a News Reporter-Staff News Editor at Biotech Week Janssen Biotech, Inc. announced that the U.S. Food and Drug Administration has approved TREMFYA? for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. "TREMFYA? represents a significant milestone in the treatmen
7/26/17 - RESVERLOGIX RECEIVES APPROVAL PATHWAY FROM THE FDA AS TO THE INCLUSION OF USA PATIENTS IN THE PHASE 3 BETONMACE TRIAL
Release date- 25072017- CALGARY,- Resverlogix Corp. is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration. Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Brochur
7/26/17 - Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial [Sport360]
Resverlogix Corp. is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration. Donald McCaffrey, President and CEO stated, "This is a major advancement for Resverlogix, having Phase 3 trial approval from both the European Authorities and
7/26/17 - Spectranetics Announces FDA Approval of Stellarex? Drug-Coated Balloon
The Spectranetics Corporation today announced receipt of U.S. Food and Drug Administration Pre-Market Approval of the Stellarex? drug-coated balloon, designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease.. Sean Lyden, ILLUMENATE Pivotal Trial s Co-Principal.
7/26/17 - Zydus Cadila gets USFDA nod for its ulcerative colitis drug [Arab Times (Kuwait)]
The company has received final approval from the United States Food and Drug Administration for Mesalamine delayed-release tablets in the strength of 800 mg, Zydus Cadila said in a statement. The group has received 27 final abbreviated new drug application approvals from the USFDA and 2 tentative ANDA approvals since January 2017, Zydus Cadila said
7/25/17 - FDA Approves TDX SP2 Power Wheelchair from Invacare
Invacare announces the recent 501(k) approval from the US Food and Drug Administration (FDA) for its TDX SP2 Power Wheelchair with LiNX Technology.
7/25/17 - Neonatal MRI Medical Device Approved by the FDA [Syrian Arab News Agency]
Medical device maker Aspect Imaging has received US Food and Drug Administration approval for its Embrace Neonatal MRI System. The imaging device is the first of its kind to be developed specifically for pediatric patients. Vasum Peiris, chief medical officer for the pediatrics and special populations at FDA`s Center for Devices and Radiological He
7/25/17 - Resverlogix Receives Approval Pathway from the FDA as to the Inclusion of USA Patients in the Phase 3 BETonMACE Trial
CALGARY, July 25, 2017/ PRNewswire/- Resverlogix Corp. is pleased to announce the receipt of a positive Type C written response from the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration. Resverlogix has agreed to make adjustments to the existing BETonMACE study protocol and to update the Investigator's Broc
7/25/17 - STRIDES SHASUN GETS USFDA NOD FOR ANTI-ALLERGY DRUG
Strides Shasun has received approval from the United States Food and Drug Administration for cetirizine hydrochloride capsules, used to relieve allergy symptoms. It has received approval for 10 milligrams liquid filled capsules OTC. The product will be manufactured at the company's facility in Bengaluru and is ready for launch.
7/25/17 - Tetracycline Safe Level Test Approved for NCIMS Appendix N Pilot Program [Arab Finance (Egypt)]
-Charm Sciences, Inc. is pleased to announce the Charm ROSA Tetracycline-SL Test has been accepted by the National Conference on Interstate Milk Shipments Laboratory Committee and Appendix N Committee as a drug residue test kit for tetracycline in its Pilot Program, set to launch July 1, 2017. The FDA evaluated methods and those that met specificat
7/25/17 - Vertera Spine Announces FDA Clearance of COALESCE? porous PEEK Lumbar Interbody Fusion Device
Vertera Spine, a developer of medical devices using advanced biomaterial technologies, today announced the COALESCE? Lumbar Interbody Fusion Device has received U.S. Food and Drug Administration 510 clearance for use in anterior, transforaminal, posterior, and lateral lumbar interbody fusion procedures. COALESCE features Vertera Spine's novel..
Articles(s): 1 - 25 of 46     Next >>     Go To Page:


© 2017 Thomson Reuters. All rights reserved.

Pharmacy News Index
  Drug Delivery Systems
  Drugstores
  FDA Final Approvals
  Front Page Healthcare News
  Generic Drugs
  Hospital Industry
  Internet Pharmacy
  IT in Healthcare
  Medicare & Medicaid
  Over-the-Counter Drugs
  Pharm Industry Trends and Policy
  Pharmaceutical Development
  Pharmaceutical Industry

FEATURED CE LESSON

Legal & Practical Issues in Compounding Pharmacy
This lesson is supported by:
RxSchool
Men's Health in Older Adults: Benign Prostatic Hyperplasia and Erectile Dysfunction
This lesson is supported by:
RxSchool
Pharmacy Spanish
This lesson is supported by:
RxSchool
Drug Therapy Management Series Part III: Geriatric Disorders
This lesson is supported by:
RxSchool

Special Announcement

Free Membership
Enjoy Drug Search, industry newsletters and more...


Websites » RxCareerCenter.comRxSchool.comClubStaffing.comNursingJobSource.comRN.com
Copyright © 2017 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415