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
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.
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
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
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
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
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
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
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
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
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
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
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...
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.
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
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
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
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
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
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.
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...
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
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
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