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 The leading web portal for pharmacy resources, news, education and careers November 24, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 24, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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10/25/17 - Alexion Pharmaceuticals Inc. - FDA Approves Soliris for the Treatment of Patients with Generalized Myasthenia Gravis
'I am pleased that the FDA recognized the comprehensive clinical data supporting the benefits of Soliris for patients with anti-AchR antibody-positive gMG,' said Professor James F. Howard, M.D., Department of Neurology at the University of North Carolina, Chapel Hill, and lead investigator in the clinical development of this new indication.' It is
10/25/17 - AstraZeneca - US FDA approves new easy to use once weekly BYDUREON BCise injectable medicine for patients with type2 diabetes
AstraZeneca today announced that the US Food and Drug Administration has approved BYDUREON BCise injectable suspension, a new formulation of BYDUREON injectable suspension in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to...
10/25/17 - Bausch + Lomb Receives 510(K) Clearance From FDA on New 3.3 Software For Victus(R) Femtosecond Laser
Bausch+ Lomb issued the following news release:. Bausch+ Lomb, a leading global eye health company, today announced it has received 510 clearance from the U.S. Food and Drug Administration for a new 3.3 software package as well as new hardware for the VICTUS (R) femtosecond laser platform, which together are designed to enhance the VICTUS (R) user
10/25/17 - FDA Approves Eculizumab for Generalized Myasthenia Gravis
James F. Howard Jr., MD, Distinguished Professor of Neuromuscular Disease, professor of neurology, medicine and allied health, and chief of the Neuromuscular Disorders Section in the UNC School of Medicine, was lead investigator of the Phase 3 REGAIN study, which helped lead to FDA approval of the drug for the treatment of this chronic and debilita
10/25/17 - Impax Announces FDA Approval and Launch of Generic Renvela Tablets 800 mg
HAYWARD, Calif.- Impax Laboratories, Inc., a specialty pharmaceutical company, today announced it has received final U.S. Food and Drug Administration approval on its Abbreviated New Drug Application for a generic version of Renvela tablets, 800 mg. Impax has immediately initiated commercialization activities. 'We are pleased to receive approval of
10/25/17 - Mayo Clinic Installs First Clinical 7T MRI Scanner
Rochester, Minn.-based Mayo Clinic will have the first clinical 7-Tesla MRI scanner in North America that has been cleared by the U.S. FDA. This MRI scanner, Siemens Healthineers' MAGNETOM Terra, will be operational at the Mayo Clinic later in 2017.
10/25/17 - NEHI urges prompt action to enable value-based contracts for innovative, high cost cancer therapies [Algeria Press Service]
The U.S. Food and Drug Administration should finalize guidance on the exchange of health care economic information on new, not-yet-approved products. NEHI also recommends that the FDA consider publishing specific guidance to allow communication about off-label uses for cancer drugs, given the likelihood that drugs approved for use in one type of ca
10/25/17 - New treatment approved for lymphoma patients
COLUMBUS- The Food and Drug Administration has approved a breakthrough cancer therapy known as CAR-T for use in adults with advanced lymphoma. It s a patient s own cells that are reinfused and go to work fighting cancer, said Samantha Jaglowski, MD, MPH, a hematologist at The Ohio State University Comprehensive Cancer Center Arthur G. J
10/25/17 - Samsung BioLogics Receives the 1st FDA Approval at the World's Largest Plant
By a News Reporter-Staff News Editor at Biotech Week Samsung BioLogics announced that on October 11, 2017, it has been licensed by the US FDA for the first monoclonal antibody Drug Substance at its second plant, the world's largest single plant. With the first license of its second plant from the FDA, Samsung BioLogics is now able to manufacture
10/24/17 - Acutus Medical Receives FDA Clearance for Advanced Cardiac Mapping Technology for Complex Arrhythmias
Acutus Medical today announced that the U.S. Food and Drug Administration has cleared the AcQMap High Resolution Imaging and Mapping System and the AcQMap 3 D Imaging and Mapping Catheter for use in patients for whom electrophysiology procedures have been prescribed. The System can also be used with existing commercially available cardia
10/24/17 - Alexion : FDA Oks Soliris To Treat Patients With Generalized Myasthenia Gravis
WASHINGTON- Alexion Pharmaceuticals Inc. said that the U.S. Food and Drug Administration has approved Soliris or eculizumab as a treatment for adult patients with generalized myasthenia gravis or gMG who are anti-acetylcholine receptor or AchR antibody-positive. Soliris is approved in the European Union for the treatment of refractory gMG in adults
10/24/17 - Corporate News Blog - GSK's Shingles Vaccine with Agenus' QS-21 Stimulon(R) Adjuvant Gets FDA Approval in US
LONDON, UK/ ACCESSWIRE/ October 24, 2017/ Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for GlaxoSmithKline PLC, following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/? The Company announced on October 20, 2017, that the US Food and Drug Admin
10/24/17 - FDA approves better vaccine against painful shingles virus
Drugmaker GlaxoSmithKline said the Food and Drug Administration approved it late Friday. Studies paid for by Glaxo indicate its vaccine is more effective, preventing shingles in about 90 percent of people. Glaxo said the price of Shingrix without insurance will be $280 for two doses.
10/24/17 - FDA Approves GSK's Shingles Vaccine with Agenus' QS-21 Stimulon Adjuvant
LEXINGTON, Mass- Agenus Inc., an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration granted marketing authorization to GlaxoSmithKline's herpes zoster vaccine, SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21 Stimulon.
10/24/17 - FDA Approves Soliris (Eculizumab) for the Treatment of Patients with Generalized Myasthenia Gravis (gMG)
Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has approved Soliris as a treatment for adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody-positive. I am pleased that the FDA recognized the comprehensive clinical data supporting the benefits of Soliris for...
10/24/17 - GSK gets approvals for `bubble boy` syndrome gene therapy in UK and shingles vaccine in US [Arab Finance (Egypt)]
GlaxoSmithKline PLC has received approvals in the UK and US for two separate treatments. The UK healthcare cost regulator has approved GSK`s gene therapy for adenosine deaminase deficiency while the US Food and Drug Administration has approved its shingles vaccine. GSK also announced in a statement that the US FDA has approved its Shingrix vaccine,
10/24/17 - GT Biopharma Announces Approved FDA IND Transfer of Its First TriKE (OXS-3550)
WASHINGTON, DC/ ACCESSWIRE/ October 24, 2017/ GT Biopharma Inc. announced today the FDA has accepted the transfer of IND 136205 Change of Sponsor from the University of Minnesota to GT Biopharma for a commercial IND of OXS-3550; a first of its kind, single-chain, tri-specific NK cell engager. OXS-3550 TriKE technology was developed by researchers a
10/24/17 - Janssen Receives Two U.S. FDA Approvals for SIMPONI ARIA for the Treatment of Adults with Active Psoriatic Arthritis or Active Ankylosing Spondylitis
HORSHAM, Pa- Biotech, Inc., announced today that the U.S. Food and Drug Administration has approved SIMPONI ARIA, the only fully-human anti-tumor necrosis factor- alpha therapy administered via a 30- minute infusion, for the treatment of adults with active psoriatic arthritis or active ankylosing spondylitis. Today's approvals follow the first FDA
10/24/17 - Ortek Therapeutics, Inc. Announces FDA Clearance For Breakthrough Electronic Cavity Detection Device
Ortek Therapeutics, Inc. today announced that the Ortek ECD? received 510 clearance from the U.S. Food and Drug Administration. The ECD was developed in the Division of Translational Oral Biology at Stony Brook University and exclusively licensed to Ortek from The Research Foundation of State University of New York. The ECD was developed by a t
10/24/17 - Perrigo Announces Tentative FDA Approval For A First-To-File Generic Version Of Picato Gel .015%
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Picato Gel 0.015%. The submission date of Perrigo's Abbreviated New Drug Application matches the first-to-file date posted on FDA's Paragraph IV Patent Certifications list. Perrigo Company plc, a leading
10/24/17 - Shingrix approved in the US for prevention of shingles in adults aged 50 and over
GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 50 years and older. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said:' Shingrix represents a significant scientific advancement in the field of vaccinology.
10/24/17 - Tandem Diabetes Care to Provide All t:slim X2 Insulin Pump Features Approved in 2018 to Users at No Cost and Expands Existing Dexcom Welcome Offer for Animas Customers
Tandem Diabetes Care , Inc., a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced that it will make any new features approved for the t: slim X2? Insulin Pump by the U.S. Food and Drug Administration in 2018 available to all in-warranty users at no cost through the Tande
10/23/17 - AstraZeneca Reports FDA Approval Of Bydureon BCise Injectable Suspension
LONDON- AstraZeneca announced US FDA has approved Bydureon BCise injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control.
10/23/17 - China Biologic Receives Approval for Commercial Manufacturing of Human Fibrinogen
By a News Reporter-Staff News Editor at Biotech Business Week China Biologic Products Holdings, Inc., a leading fully integrated plasma-based biopharmaceutical company in China, announced that Shandong Taibang Biological Products Co., Ltd., the Company's majority-owned subsidiary, has received approval from the China Food and Drug Administration
10/23/17 - Faxitron Announces FDA 510k Clearance of VersaVision, a Next Generation Digital Imaging System Designed to Increase Precision and Improve Workflow in...
Faxitron Announces FDA 510 k Clearance of VersaVision, a Next Generation Digital Imaging System Designed to Increase Precision and Improve Workflow in Clinical Settings. By a News Reporter-Staff News Editor at Pharma Business Week Faxitron, a global leader in best-in-class imaging systems for medicine and life science research, announced that the
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