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 The leading web portal for pharmacy resources, news, education and careers December 22, 2014
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - December 22, 2014

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 83     Next >>     Go To Page:

12/22/14 - BioCryst gets FDA approval for flu drug Rapivab
NEW YORK BioCryst Pharmaceuticals said Monday that U.S. regulators approved its drug Rapivab, an intravenous treatment for the flu. Shares of BioCryst Pharmaceuticals Inc. rose 17 cents to $11.33 in morning trading. Rapivab, or peramivir, was approved in Japan and South Korea in 2010 and is marketed in Japan by Shionogi and Co. It is only availa
12/22/14 - BioCryst says FDA approves oral flu drug Rapivab
NEW YORK BioCryst Pharmaceuticals said Monday that U.S. regulators approved its drug Rapivab, an intravenous treatment for the flu. Shares of BioCryst Pharmaceuticals Inc. rose 17 cents to $11.33 in morning trading. Rapivab, or peramivir, was approved in Japan and South Korea in 2010 and is marketed in Japan by Shionogi and Co. It is only availa
12/22/14 - BioCryst's RAPIVAB(TM) (peramivir injection) Receives FDA Approval for the Treatment of Acute Uncomplicated Influenza
BioCryst Pharmaceuticals, Inc., a pharmaceutical company focused on the development and commercialization of treatments for rare and infectious diseases, today announced that the U.S. Food and Drug Administration has approved RAPIVAB, an intravenous neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years an
12/22/14 - Bristol-Myers Squibb Announces U.S. FDA Approval of Opdivo (nivolumab)
Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has approved Opdivo. Bristol-Myers Squibb is a global pharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company Media: Sarah Koenig, 609-252-4145..
12/22/14 - ContraFect Receives FDA Approval to Initiate Clinical Trials of CF-301 for MRSA Bloodstream Infections
ContraFect Corporation, a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, announced today that the U.S. Food and Drug Administration completed the review of its submission and has removed the full clinical hold on ContraFect's...
12/22/14 - DGAP-Adhoc: LifeWatch receives FDA 510(k) clearance for its Vital Signs Patch (VSP)
EQS Group-Ad-hoc: LifeWatch AG/ Key word: Miscellaneous LifeWatch receives FDA 510 clearance for its Vital Signs Patch 22.12. 2014/ 07:00 Release of an ad hoc announcement pursuant to Art. 53 KR. The issuer is solely responsible for the content of this announcement.- Press Release
12/22/14 - DGAP-Adhoc: LifeWatch receives FDA 510(k) clearance for its Vital Signs Patch (VSP) (english)
LifeWatch receives FDA 510 clearance for its Vital Signs Patch EQS Group-Ad-hoc: LifeWatch AG/ Key word: Miscellaneous LifeWatch receives FDA 510 clearance for its Vital Signs Patch 22.12. 2014/ 07:00 Release of an ad hoc announcement pursuant to Art. 53 KR. The issuer is solely responsible for the content of this announcement.-
12/22/14 - GNW-News: PEH's Portfolio Company Enanta announces U.S. FDA Approval for AbbVie's VIEKIRA PAK(TM) (english)
FDA Approval for AbbVie's VIEKIRA PAK (TM). Private Equity Holding AG/ PEH's Portfolio Company Enanta announces U.S. Zug, December 22, 2014 Enanta Pharmaceutical Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field is Private Equity Holding AG's largest..
12/22/14 - Jakafi ruxolitinib receives expanded approval for treatment of polycythemia vera; available through Diplomat
By a News Reporter-Staff News Editor at Hematology Week Diplomat Pharmacy, Inc., the nation's largest independent specialty pharmacy, announced that the U.S. Food and Drug Administration has approved an expanded indication of Jakafi. Jakafi received expanded approval for use in the treatment of polycythemia vera under the FDA's priority review pr
12/22/14 - MP Biomedicals Receives First Ever FDA Approval for HTLV Confirmatory Assay
By a News Reporter-Staff News Editor at Pharma Business Week MP Biomedicals, LLC, a leading provider of life science reagents, fine chemicals and diagnostic products, announced that it has received FDA approval on the MP Diagnostics HTLV Blot 2.4, a Western Blot for HTLV confirmatory testing and viral type discrimination. MP Biomedicals continues
12/22/14 - MRA Applauds Latest Melanoma Drug Approval
The Melanoma Research Alliance today welcomed news that the U.S. Food& Drug Administration has granted approval to Bristol Myers-Squibb s new immunotherapy drug, Opdivo , for the treatment of metastatic melanoma. It is the second anti-PD-1 drug, aimed at re-energizing a patient s protective immune response to cancer, to have earned FDA appr
12/22/14 - Mylan Launches First Generic Version of Vivelle-DOT
Mylan received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for this product, which is indicated for the treatment of moderate to severe vasomotor symptoms and moderate to severe symptoms of vulvar and vaginal atrophy due to menopause; hypoestrogenism due to hypogonadism, castration or primary o
12/22/14 - New ZEISS Integrated Intraoperative OCT Provides Surgeons Unprecedented Views of Transparent Ocular Structures in a Surgical Microscope
The U.S. Food and Drug Administration has cleared RESCAN 700 for sale in the United States, bringing to U.S. ophthalmologists an emerging technology that aims to overcome the trouble surgeons may have in seeing certain anatomical details during eye surgery. High-definition OCT images appear directly in the LUMERA 700 microscope eyepiece, adding a r
12/22/14 - PEH's Portfolio Company Enanta announces U.S. FDA Approval for AbbVie's VIEKIRA PAK(TM)
Private Equity Holding AG/ PEH's Portfolio Company Enanta announces U.S. Zug, December 22, 2014 Enanta Pharmaceutical Inc., a research and development-focused biotechnology company dedicated to creating small molecule drugs primarily in the infectious disease field is Private Equity Holding AG's largest direct investment. Enanta has announced that.
12/22/14 - Sorin Group Receives FDA Clearance for Memo 3D ReChord [Health & Beauty Close - Up]
Sorin Group reported the U.S. Food and Drug Administration clearance for Memo 3 D ReChord, a semi-rigid annuloplasty ring for mitral valve repair. According to a release from the company, the new Memo 3 D ReChord, Sorin Group's latest advancement in mitral valve repair, incorporates a chordal guide system into the existing Memo 3 D ring to simplify
12/22/14 - xStage Receives FDA Clearance for Home Nocturnal Hemodialysis
NxStage Medical, Inc., a leading manufacturer of innovative dialysis products, announced today that the U.S. Food and Drug Administration has cleared its System One? to perform hemodialysis overnight while the patient is at home sleeping, known as home nocturnal hemodialysis. NxStage's System One is the first and only hemodialysis machine clea
12/21/14 - ArtVentive Medical Secures FDA Clearance for EOS Device [Manufacturing Close - Up]
ArtVentive Medical Group recently received U.S. Food and Drug Administration clearance for the Endoluminal Occlusion System. Anthony Venbrux, Interventional Radiologist at The George Washington University Hospital in Washington, D.C. "In my experience with the device, it has shown immediate and complete vascular occlusion upon deployment.
12/21/14 - FDA approves Teva allergy spray for children [Globes, Tel Aviv, Israel]
Dec. 21 Teva Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration has approved the 40 mcg version of its QNASL nasal spray for the treatment of nasal symptoms associated with allergic rhinitis in children aged 4-11.. QNASL 40 mcg is a lower dose formulation of QNASL Nasal Aerosol, currently available by prescripti
12/21/14 - Incyte Gets FDA Approval for Jakafi (ruxolitinib) [Professional Services Close - Up]
Incyte Corp. recently reported that the U.S. Food and Drug Administration has approved Jakafi for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi, an oral medication, is the first and only product approved by the FDA for PV, a rare and progressive blood cancer.
12/21/14 - Incyte: U.S. Food and Drug Administration Approves Jakafi for Uncontrolled Polycythemia Vera [Professional Services Close - Up]
Incyte Corp. recently reported that the U.S. Food and Drug Administration has approved Jakafi for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. In a release, the Company noted that PV is a rare and progressive blood cancer. For the first time we are able to provide these pa
12/21/14 - Mylan Gets Tentative FDA Approval for Paediatric Formulations of Abacavir/lamivudine [Professional Services Close - Up]
Mylan recently reported that its subsidiary Mylan Laboratories Limited has received tentative approval from the U.S. Food and Drug Administration for its New Drug Applications for two dosages of abacavir/lamivudine tablets for oral suspension for the treatment of HIV-1 infection in paediatric patients. Dominique Limet, CEO ViiV Healthcare commented
12/20/14 - HeartFlow Secures De Novo Clearance from the U.S. Food and Drug Administration for Breakthrough FFRCT Technology
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week HeartFlow Inc., a pioneer in personalized medical technology for cardiovascular disease, announced that it received de novo clearance from the U.S. Food and Drug Administration for its FFRCT technology. HeartFlow FFRCT is the first and only non-invasive imaging technology for
12/20/14 - Jazz Pharmaceuticals Receives FDA Approval For Intravenous Administration Of Erwinaze (asparaginase Erwinia chrysanthemi)
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration approved the intravenous administration of Erwinaze . "Administration of Erwinaze through an intravenous infusion provides physicians another option for patients, including those who cannot tolerate intramuscular injections," said Jeffrey Tobias, M.D., executiv
12/19/14 - AbbVie Receives U.S. FDA Approval of VIEKIRA PAK? (Ombitasvir/Paritaprevir/Ritonavir Tablets; Dasabuvir Tablets) for the Treatment of Chronic Genotype 1 Hepatitis C
The U.S. Food and Drug Administration has approved AbbVie's VIEKIRA PAK?, an all-oral, interferon-free treatment, with or without ribavirin, for the treatment of patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis. "We are proud of the work of our research and development organization to bri
12/19/14 - AstraZeneca cancer drug, companion test approved
TRENTON, N.J. U.S. regulators on Friday granted accelerated approval to the first in a new class of targeted drugs for ovarian cancer, Lynparza from British drugmaker AstraZeneca PLC. The Food and Drug Administration also approved a companion diagnostic test from Myriad Genetics Inc. of Salt Lake City called BRACAnalysis CDx. Richard Pazdur, dir
Articles(s): 1 - 25 of 83     Next >>     Go To Page:


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