'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
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...
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
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
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
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.
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
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
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
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
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
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
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.
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.
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...
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,
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
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
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
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
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.
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
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.
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
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