Register Now
Why register?
Login
 The leading web portal for pharmacy resources, news, education and careers February 10, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 10, 2016

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 41     Next >>     Go To Page:

2/9/16 - 3 parent embryos approved
The committee, which was convened last year at the request of the US Food and Drug Administration, concluded it is ethically permissible to go forward, but with caution with mitochondrial replacement techniques, said chairman Jeffrey Kahn, a bioethicist at Johns Hopkins University. But the advisory panel s conclusions have slammed into a c
2/9/16 - Bristol-Myers Squibb receives approval from US FDA for Daklinza hepatitis C treatment
Bristol-Myers Squibb, a global biopharmaceutical company, has received approval from the US Food and Drug Administration for its hepatitis drug, Daklinza, an NS5A replication complex inhibitor for expanded use, it was reported yesterday. The drug can be taken in combination with sofosbuvir, with or without ribavirin in genotypes 1 and 3.
2/9/16 - FDA Approves First MR-Conditional CRT-D Devices
Release date- 08022016- Medtronic announced Friday that FDA has approved the the first MR-conditional cardiac resynchronization therapy defibrillators for the treatment of heart failure in the U.S.. J. Rod Gimbel, Case Western Reserve University, in a Medtronic news release.' This is a significant development for heart failure patients with CRT-D t
2/9/16 - India,United States : US FDA cleared psoriasis drug of arm of DR REDDY [TendersInfo (India)]
The Hyderabad- based multinational pharmaceutical company Dr Reddy today has announced that its US subsidiary Promius PharmaTM, LLC, has been successful to secure clearance from the US FDA for its psoriasis treatment Sernivo. In a statement, the pharmaceutical giant revealed, "Subsidiary, Promius PharmaTM, LLC, has received approval for Sernivo Spr
2/9/16 - Medtronic gets FDA approval for MRI-safe defibrillators [Star Tribune (Minneapolis)]
Feb. 09 Medtronic has secured government approval to sell resynchronization defibrillators that are safe to use with magnetic resonance imaging the third time in five years that the Minnesota- run medical device company has scored first-to-market status for products with the sought-after feature. Medicare does not pay for MRI scans done on peop
2/9/16 - Promius Pharma Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
Release date- 08022016- Hyderabad, India& Princeton, NJ, USA.: Dr. Reddy' a announced today that its US subsidiary, Promius PharmaTM, LLC, U.S., has received approval for Sernivo Spray, 0.05% from the U.S. Food and Drug Administration. Commenting on the approval, G V Prasad, Co-Chairman and CEO, Dr. Reddy's Laboratories said' The FDA approval of Se
2/9/16 - Seattle Genetics Reports Fourth Quarter and Year 2015 Financial Results
Seattle Genetics, Inc. today reported financial results for the fourth quarter and year ended December 31, 2015. For ADCETRIS, we achieved record sales in the fourth quarter and for the year, received FDA approval for an expanded label, completed enrollment in two of three ongoing phase 3 trials and continued our efforts to establish ADCETRIS as th
2/8/16 - Bonnie J. Addario Lung Cancer Foundation Honors Bristol-Myers Squibb for Improving and Advancing Breakthrough Treatments for Lung Cancer [Global Data Point]
Teresa Bitetti, Senior Vice President of Oncology for Bristol-Myers Squibb accepted the award in San Francisco on November 14, 2015.&# x0D;. "With its immuno-oncology research, Bristol-Myers Squibb revolutionized the approach to lung cancer treatment, ushering in a new and hopeful era. Bristol-Myers Squibb received FDA approval for the first immun
2/8/16 - Bristol-Myers Squibb's Opdivo nivolumab + Yervoy ipilimumab Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF...
Bristol-Myers Squibb's Opdivo nivolumab+ Yervoy ipilimumab Regimen Receives Expanded FDA Approval in Unresectable or Metastatic Melanoma Across BRAF Status1. By a News Reporter-Staff News Editor at Biotech Business Week Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration has approved Opdivo in combination with Yervoy
2/8/16 - Dako, an Agilent Technologies Company, Announces Expanded FDA Approval of Complementary Diagnostic Test to Include Melanoma
By a News Reporter-Staff News Editor at Biotech Business Week Dako, an Agilent Technologies company and a worldwide provider of cancer diagnostics, announced that the U.S. Food and Drug Administration has approved the expansion of the intended use of Dako PD-L1 IHC 28-8 pharmDx to include patients with melanoma. "We are truly excited about the F
2/8/16 - Dr. Reddy's Says Sernivo Spray 0.05% For Plaque Psoriasis Gets FDA Approval
NEW DELHI- Dr. Reddy's Laboratories Ltd. announced Monday that its US subsidiary Promius Pharma LLC, U.S. has received approval for Sernivo Spray, 0.05% from the U.S. Food and Drug Administration or FDA. India- based drug maker noted that Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoria
2/8/16 - Dr. Reddy's US unit Promius gets USFDA nod for Sernivo spray [India Infoline News Service]
Dr. Reddy's announced that its US subsidiary, Promius Pharma, LLC, U.S.has received approval for Sernivo Spray, 0.05% from the U.S. Food and Drug Administration. The commercial launch of the product is planned for the coming quarter. Commenting on the approval, G V Prasad, Co-Chairman and CEO, Dr. Reddy's Laboratories said "The FDA approval of Sern
2/8/16 - FDA Approves Eisai's Halaven eribulin mesylate Injection for the Treatment of Patients with Advanced Liposarcoma
By a News Reporter-Staff News Editor at Clinical Trials Week Eisai Inc. announced that the U.S. Food and Drug Administration approved Halaven Injection for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen. This marks the second indication for which Halaven has been...
2/8/16 - FDA Approves Takeda's Dexilant SoluTab dexlansoprazole
By a News Reporter-Staff News Editor at Pharma Business Week Takeda Pharmaceuticals U.S.A., Inc., announced that the United States Food and Drug Administration approved Dexilant SoluTab delayed-release orally disintegrating tablets, a new formulation of dexlansoprazole that can be taken by allowing the tablet to melt in the patient's mouth.
2/8/16 - Medtronic First to Receive FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators
Release date- 05022016- DUBLIN- Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for the first and only magnetic resonance imaging conditional cardiac resynchronization therapy defibrillators for the treatment of heart failure. Known as the world's largest and leading cardiac device manufacturer, Medtron
2/8/16 - Promius Pharma? Receives FDA Approval for Sernivo (betamethasone dipropionate) Spray, 0.05%
HYDERABAD, India& PRINCETON, N.J. Dr. Reddy s announced today that its US subsidiary, Promius Pharma TM, LLC, U.S., has received approval for Sernivo? Spray, 0.05% from the U.S. Food and Drug Administration. We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology pro
2/8/16 - RBCC: Drug Approvals Show Personalized Medicine Gaining Favor with Feds and Public [Global Data Point]
According to the Personalized Medicine Coalition- a nationwide advocacy group that promotes the understanding and adoption of personalized medicine- more than one in four new drugs approved by the FDA last year were personalized medicine drugs. In addition, the PMC notes the FDA approved "a number of significant new personalized medicine indication
2/8/16 - Sangamo BioSciences Announces FDA Clearance Of Investigational New Drug Application For ZFN-Mediated Genome Editing Treatment Of MPS I
Sangamo BioSciences, Inc., the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration has cleared the Company's Investigational New Drug application for SB-318, a single treatment strategy intended to provide a life-long therapy for Mucopolysaccharidosis Type I. The SB-318 IND application is now active and enab
2/6/16 - India,United States : AUROBINDO PHARMA gets US FDA approval for levertiracetam injection & ceecoxib capsules [TendersInfo (India)]
The US Food& Drug Administration has granted approval to Aurobindo Pharma for the manufacturing and commercialising levetiracetam injection USP, 500 mg/5 mL single dose vials and for celecoxib capsules, 50 mg, 100 mg, 200 mg and 400 mg. As per the release, the first approved ANDA is bioequivalent and therapeutically equivalent to the reference list
2/6/16 - LUPIN EXPECTS TO END YEAR WITH MORE US APPROVALS; NET PROFIT ON RECOVERY PATH
Lupin Ltd expects to obtain 25 product approvals from the US Food and Drug Administration in 2015-2016. The company has reported a net profit of Rs529 crore for Oct- Dec 2015. Its total revenue has gone up to Rs3, 555 crore. The company has received 133 approvals from the USFDA so far.
2/5/16 - Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE dalbavancin
By a News Reporter-Staff News Editor at Drug Week Allergan plc, a leading global pharmaceutical company, announced the U.S. Food and Drug Administration has approved the company's supplemental new drug application to update the label for DALVANCE for injection. "Hospitals are facing pressures to reduce hospitalizations and readmissions, while...
2/5/16 - CSPC Pharm approved to start clinical trials for 28 products [ET Net News (China)]
CSPC Pharmaceutical said the Group has. recently been granted approval from the China Food and Drug Administration to commence. clinical trials for 28 products developed by the Group.
2/5/16 - India,United States : US FDA Okays AUROBINDO PHARMA to manufacture and market Isosulfan Blue Injection [TendersInfo (India)]
Aurobindo Pharma Limited has secured final approval from the US Food& Drug Administration to manufacture and market Isosulfan Blue Injection, 1% single-dose vials. It is informed that the approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product LymphazurinTM Injection, 1%, of Covidien. Now, Aurobindo holds
2/5/16 - Medtronic First to Receive FDA Approval for MR-Conditional Cardiac Resynchronization Therapy-Defibrillators
Amplia MRI (TM) and Compia MRI (TM) CRT-Ds, Approved for Patients with Heart Failure, Can Safely Undergo Full Body MRI Scans DUBLIN- Feb. 5, 2016- Medtronic plc today announced that it has received U.S. Food and Drug Administration approval for the first and only magnetic resonance imaging conditional cardiac resynchronization therapy defibrillator
2/5/16 - Novel cancer vaccine in combination with check point blockades holds promise
AUSTIN, Texas, Feb. 5, 2016/ PRNewswire-iReach/ Elios Therapeutics begins enrollment of phase I/IIa melanoma trial combining approved check point inhibitors with the Elios personalized cancer vaccine. Elios Therapeutics, LLC, has received FDA approval to proceed with a 45- patient study that will combine the company's novel autologous vaccine tec
Articles(s): 1 - 25 of 41     Next >>     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:
Hands on Spanish
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