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 The leading web portal for pharmacy resources, news, education and careers February 14, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 14, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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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
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