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 The leading web portal for pharmacy resources, news, education and careers February 12, 2016
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - February 12, 2016

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 39     Next >>     Go To Page:

2/12/16 - Researchers from Food and Drug Administration Discuss Findings in Gene Therapy (Gene therapy for cancer: regulatory considerations for approval)
By a News Reporter-Staff News Editor at Angiogenesis Weekly A new study on Biotechnology is now available. Our news journalists obtained a quote from the research from Food and Drug Administration, "At the time of this writing, no gene therapy product has been approved by the United States Food and Drug Administration. For more information on thi
2/11/16 - Guerbet receives FDA 510k clearance for the OptiOne? Single-Head Contrast Delivery System
The US clearance confirms Guerbet's international focus in providing innovative imaging solutions to serve wider customer needs. Guerbet will present the injector at the upcoming European Congress of Radiology. "We are extremely pleased to announce the availability of this newest injector system, as we believe that it offers additional flexibility
2/11/16 - Lannett Receives FDA Approval For Temozolomide Capsules
Lannett Company, Inc. today announced that its wholly owned subsidiary, Kremers Urban Pharmaceuticals Inc., has received approval from the U.S. Food and Drug Administration of its Abbreviated New Drug Application for Temozolomide Capsules 5 mg, 20 mg, 100 mg, 140 mg, 180 mg and 250 mg, the therapeutic equivalent to the reference listed drug Temod
2/11/16 - NAFDAC Approves Local Production of Life Saving Drugs
The National Agency for Food and Drug Administration and Control, NAFDAC, has approved the production of four United Nations life saving commodities for women and children. Paul Orhii, who spoke at a two-day Common Technical Document, CTD, workshop in Lagos, said, Nigerians now have improved access to locally produced safe, efficacious and affordab
2/11/16 - Philips secures 510(k) clearance to market new patient monitoring solution to bring bedside quality monitoring to the MR suite
ANDOVER, MA. Royal Philips today announced the Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging, has received 510 clearance from the U.S. Food and Drug Administration. The MR400 provides ICU-comparable, bedside quality monitoring in the MR suite for all patients, including those with serious medical.
2/11/16 - Zimmer Biomet Announces FDA Clearance for Unite3D? Bridge Fixation System
WARSAW, Ind., Feb. 11, 2016/ PRNewswire/ Zimmer Biomet Holdings, a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510 clearance from the U.S. Food and Drug Administration for the Unite3D? Bridge Fixation System, a groundbreaking 3 D-printed technology designed to offer stability in foot and ank
2/10/16 - American College of Rheumatology Encourages Safe Adoption of Biosimilars During FDA Public Hearing on CT-P13, a Proposed Biosimilar for Infliximab (Remicade)
During a public meeting held Tuesday by the Food and Drug Administration' s Arthritis Advisory Committee to review the license application of CT-P13, the American College of Rheumatology provided recommendations for policy guidelines to implement as the committee decides whether to license additional biosimilars for sale in the U.S. If approved,
2/10/16 - Avanir Pharmaceuticals Announces FDA Approval of ONZETRA Xsail AVP-825 for the Acute Treatment of Migraine in Adults
By a News Reporter-Staff News Editor at Biotech Week Avanir Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has approved ONZETRA? Xsail?, formerly known as AVP-825, for the acute treatment of migraine with or without aura in adults. Given this high dissatisfaction, there remains an unmet need to provide patients wit
2/10/16 - FDA approves Adaptimmune Therapeutics 'breakthrough' cancer treatment [The Philadelphia Inquirer]
Feb. 10 Adaptimmune Therapeutics, a biopharmaceutical company with U.S. operations in Philadelphia, said Tuesdaythe Food and Drug Administration has granted "breakthrough therapy designation" for its TCR engineered T-cell therapy to treat cancer. Adaptimmune, which has a collaboration and licensing agreement with GlaxoSmithKline to commercialize
2/10/16 - FDA Grants Priority Review to KemPharm for KP201/APAP NDA
KemPharm, Inc. today announced that the New Drug Application for KP201/APAP, its investigational drug candidate for the short-term management of acute pain, has been accepted and granted priority review by the U.S. Food and Drug Administration. We believe this milestone brings us one step closer to providing prescribers and patients with a new
2/10/16 - Lice Clinics of America Opens New Treatment Center in Central Mississippi
But thanks to the opening of a new Lice Clinics of America clinic, moms in Central Mississippi no longer have to worry about treating the icky bugs themselves. Lice Clinics of America provides screening, diagnosis and treatment options for people infested with head lice. The clinic is staffed by certified operators of the AirAll device, an FDA- c
2/10/16 - MX Orthopedics Receives FDA Clearance on the dynaMX? Compression Staple
MX Orthopedics Corp. is a privately held company focused on improving implant/bone fixation. MXO is proud to announce the recent FDA clearance of the dynaMX? Compression Staple. MXO's dynaMX? line of fracture fixation implants include: superelastic compression staples, screws, plates, and intramedullary implants.
2/10/16 - OptiNose Announces FDA Approval for ONZETRA? Xsail? sumatriptan nasal powder, a New Treatment for Acute Migraine Using Bi-Directional? Breath...
By a News Reporter-Staff News Editor at Biotech Week OptiNose, a privately-held specialty biopharmaceutical company, announced that its licensing partner, Avanir Pharmaceuticals, Inc. has reported that the U.S. Food& Drug Administration approved ONZETRA? Xsail?, formerly AVP-825, for the acute treatment of migraine with or without aura in adu
2/10/16 - Philips secures 510(k) clearance to market new patient monitoring solution to bring bedside quality monitoring to the MR suite
ANDOVER, MA. Royal Philips today announced the Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging, has received 510 clearance from the U.S. Food and Drug Administration. The MR400 provides ICU-comparable, bedside quality monitoring in the MR suite for all patients, including those with serious medical.
2/10/16 - Seattle Genetics Reports Fourth Quarter and Year 2015 Financial Results [Global Data Point]
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 the foundation of care for CD30-expressing lymphomas, "said Clay Siegall, Ph.D., President and Chief Executive Offi
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
Articles(s): 1 - 25 of 39     Next >>     Go To Page:


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