Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers May 29, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - May 29, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
<< Back     Articles(s): 26 - 38 of 38     Go To Page:

5/24/16 - IDegLira receives positive 16-0 vote in favour of approval from FDA Advisory Committee
Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes. The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA'
5/24/16 - IDegLira receives unanimous 16-0 vote in favor of approval from FDA Advisory Committee
Based on the data contained in the New Drug Application for IDegLira, the FDA asked the panel members to discuss whether Novo Nordisk has provided adequate evidence to establish the efficacy and safety profile of IDegLira for the treatment of adults with type 2 diabetes. The NDA for IDegLira was submitted to the FDA in September 2015 under the FDA'
5/24/16 - Perimeter Medical Imaging Receives FDA Clearance for OTISTM Optical Tissue Imaging System
Perimeter Medical Imaging, Inc., an innovative medical imaging company whose mission is to revolutionize tissue removal surgery for surgeons and patients, today announced receipt of U.S. Food and Drug Administration 510 clearance for its OTIS TM 1.0 Optical Coherence Tomography System. Ted James, Medical Director of Skin& Soft Tissue Surgical Oncol
5/24/16 - Regen BioPharma, Inc. Files Application to Trade Publicly on OTCQB
Regen BioPharma, Inc.,, and has applied to OTC Markets Group Inc. to uplist Regen's Common and Series A Preferred shares to the OTCQB Venture Marketplace. Regen BioPharma Inc. has cleared an investigational new drug application with the U. S. Food and Drug Administration and is preparing to enter Clinical Phase I in the treatment for aplastic anemi
5/24/16 - SELLAS? Life Sciences Announces Upcoming Presentation of Phase 2 Clinical Results for WT1 Cancer Vaccine at the 2016 ASCO Annual Meeting
ZUG, Switzerland and NEW YORK, May 24, 2016/ PRNewswire/ SELLAS? Life Sciences Group, a development-stage biopharmaceutical company with its main focus on developing innovative products to treat cancer, today announced that results from a Phase 2 trial of the Company's WT1 cancer vaccine, galinpepimut-S, in patients with acute myeloid leukemia
5/24/16 - Seqirus Gets FDA Approval For Flucelvax Quadrivalent For 4 Yrs Of Age And Older
BASEL- Seqirus, part of CSL Limited, said that the US Food and Drug Administration has approved Flucelvax Quadrivalent or Influenza Vaccine, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B virus
5/24/16 - Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT? (Influenza Vaccine) for people four years of age and older
Seqirus announced today that the US Food and Drug Administration has approved FLUCELVAX QUADRIVALENT?, the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older. 1,2 FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B viruses recommended by the World H
5/23/16 - Avantis Medical Systems Receives 510(k) Clearance from FDA for Resposable Third Eye Panoramic? Device for Colonoscopy
Avantis Medical Systems, Inc., a technology leader in developing novel digital imaging devices, today announced that it has received 510 clearance from the U.S. Food& Drug Administration for its Third Eye Panoramic? device for use as a resposable product for colonoscopies. Previously cleared as a disposable device, this latest clearance now
5/23/16 - CASI Pharmaceuticals Receives Approval From CFDA To Conduct Phase 2 Clinical Trial With ENMD-2076 For Fibrolamellar Carcinoma FLC
By a News Reporter-Staff News Editor at Clinical Trials Week CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to innovative therapeutics addressing cancer and other unmet medical needs, announces that China's Food and Drug Administration has approved the Company's application to conduct a Phase 2 clinical trial in fibrolamellar..
5/23/16 - Diadexus, Inc. and Sonic Healthcare USA Sign National Agreement for PLAC(R) Activity Test
Diadexus, Inc., a diagnostics company developing and commercializing products that aid in assessing the prognosis of cardiac disease, today announced it has signed an agreement with Sonic Healthcare USA to launch the company's PLAC Activity Test into Sonic's national network of laboratories. The PLAC Test for Lp-PLA2 Activity is the only FDA-
5/23/16 - Infusion Pump Provides EMR Integration, Improved Security
Hospira has received FDA clearance for the LifeCare PCA 7.0 infusion system, the first PCA infusion pump to enable integration with the electronic medical record. The system also offers enhanced cybersecurity protections like hospital-configured device passwords to prevent unauthorized access.
5/23/16 - Wet Original Personal Lubricant Receives FDA 510k Medical Device Clearance from Food and Drug Administration
"It's a good thing the FDA has been cracking down on the lubricant industry, requiring every lubricant on the market to submit a 510 application to the FDA in order to legally be marketed. Consumers need to understand that Personal Lubricants are applied to mucous membranes and are very easily absorbed into the body, so it's important to make sure
5/22/16 - Eisai Announces FDA Approval of FYCOMPA perampanel Oral Suspension for Adjunctive Therapy in the Treatment of Partial-Onset Seizures and Primary...
By a News Reporter-Staff News Editor at Medical Letter on the CDC& FDA Eisai Inc. announced that the U.S. Food and Drug Administration has approved FYCOMPA CIII Oral Suspension as adjunctive therapy for the treatment of partial-onset seizures with or without secondarily generalized seizures, and primary generalized tonic-clonic seizures in patien
<< Back     Articles(s): 26 - 38 of 38     Go To Page:


© 2016 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

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.comRxProHealth.comNursingJobSource.comNurseZone.comRN.com
Copyright © 2009 Pharmacy Choice - All rights reserved.
Terms and Conditions | Privacy Statement
888-682-4415