WASHINGTON- Actavis plc announced the U.S. Food and Drug Administration has approved AVYCAZ. AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens. AVYCAZ was granted priority review and approval as a Qualified Infectious Disease Product in accordance with the Generating Antibi
Cytori Therapeutics, Inc. announced today that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. Steven Kesten, Chief Medical Officer of Cytori Therapeutics. There are only about 35 specialized scleroderma centers in the U.S. and this decision to expand the trial si
Glenmark Pharmaceuticals has received approval from the United States Food and Drug Administration for generic Ashiyna contraceptive tablets. It has launched these tablets in the United States market. Glenmark Generics Inc, USA, a subsidiary of Glenmark, has introduced Ashiyna extended-cycle oral contraceptive tablets, which are equivalent of Teva.
Medtronic plc today announced U.S. Food and Drug Administration approval for VenaSeal (TM) closure system, a minimally invasive procedure that uses a specially formulated medical adhesive to close lower superficial extremities such as the great saphenous vein in patients with symptomatic venous reflux. Venous reflux disease, also known as chronic..
PARIS- Sanofi announced that the U.S. Food and Drug Administration or FDA) approved Toujeo (insulin glargine injection, 300 U/mL), a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. The approval of Toujeo was based on FDA review of results from the EDITION clinical trial program, wh
Sanofi Receives FDA Approval of Once-Daily Basal Insulin Toujeo Paris, France- February 26, 2015- Sanofi announced today that the U.S. Toujeo is expected to be available in the U.S. at the beginning of Q2 2015. " Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the managemen
PARIS, Feb. 25, 2015/ PRNewswire-USNewswire/ Sanofi announced today that the U.S. Food and Drug Administration approved Toujeo , a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. "Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which
The FDA recently expanded the existing indication for Celgene's lenalidomide in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. The drug was approved through the FDA priority review process which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may prov
AVYCAZ is part of Actavis' leading portfolio of infectious disease products that address some of the most dangerous pathogens. "The FDA approval of AVYCAZ is an important step forward in enhancing our ability to respond to serious infections caused by difficult to treat Gram-negative pathogens," said David Nicholson, Executive Vice President, Glob
The drug from Actavis PLC contains two ingredients, cephalosporin and avibactam, designed to help fight antibiotic-resistant bacteria. The Food and Drug Administration approved Avycaz to treat certain abdominal infections, in combination with another drug, and for complicated urinary-tract infections, including kidney infections, for which there ar