Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, announced that it has received FDA 510 clearance of its Therapeutic Lung Flute. The application follows the successful completion of a clinical trial at the University at Buffalo and the Western
WILMINGTON, Del., Feb. 8AstraZeneca today announced that the US Food and Drug Administration has approved CRESTOR to reduce the risk of stroke, myocardial infarction and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease based on age, high-sen
YM BioSciences Inc., announced that the FDA has advised the Company that it may now enroll patients at US clinical sites into two ongoing randomized, double-blind Phase II trials of its lead product, nimotuzumab. The current trial designs were informed by previous trials with nimotuzumab in the same indications.
Amneal Pharmaceuticals is pleased to announce that it received U.S. FDA approval to manufacture combination Tramadol HCl in 37.5 mg strength and Acetaminophen in 325 mg strength in tablet form effective December 9, 2009. Tramadol/APAP is a centrally-acting analgesic indicated for the short-term management of moderately severe acute pain.
02/08/10 Atossa Genetics, Inc., a privately-held healthcare company focused on the development and marketing of novel cellular and molecular diagnostic risk assessment products for breast cancer, announced today the launch of its new Web site at www.atossagenetics.com. Founded in 2009 by Steven C. Quay, M.D., Ph.D., Atossa Genetics, Inc. is comm
Aubrey Inc., an advanced wound care company, announced it has received clearance from the US Food and Drug Administration to market the AWBAT Plus product line in the United States. Like the initial AWBAT product line, AWBAT Plus consists of bioengineered wound dressings that are intended to close the wound and allow the body to heal in a moist env
Calibra Medical announced that the U.S. Food and Drug Administration has cleared Finesse, the company's insulin patch-pen. "Finesse combines the fast, discreet, needle-free features of wearable insulin pumps with the non-electronic simplicity, safety and affordability of insulin pens," said Calibra's Chairman and CEO, Jeffrey Purvin.
Calibra Medical announced that the U.S. Food and Drug Administration has cleared Finesse, the company's insulin patch-pen. "Finesse combines the fast, discreet, needle-free features of wearable insulin pumps with the non-electronic simplicity, safety and affordability of insulin pens," said Calibra's Chairman and CEO, Jeffrey Purvin.
The U.S. Food and Drug Administration today approved Ampyra extended release tablets to improve walking in patients with multiple sclerosis. MS is a chronic, often disabling, disease that affects the central nervous systemthe brain, spinal cord, and optic nerves. The progress, severity, and specific symptoms of MS are unpredictable and vary from
Beech Tree Labs, Inc., announced that the FDA has approved its IND for a 180 patient Phase 1/2a clinical evaluation of BTL-TML001, a novel therapeutic agent for treating acute influenza virus infections. In the United States it is estimated that outbreaks of seasonal flu incur annual costs of more than $12 billion with a mortality rate of over 36,0
The U.S. Food and Drug Administration today approved Victoza, a once-daily injection to treat type 2 diabetes in some adults. Victoza is intended to help lower blood sugar levels along with diet, exercise, and selected other diabetes medicines. Insulin is a hormone that helps prevent sugar from building up in the blood.
BALTIMORE, Feb. 8Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. Lupin's Amlodipine/Benazepril capsules are the AB-rated generic equivalent of Novartis' Lotrel capsules indicated for the treatment
Medicsight PLC, a subsidiary of MGT Capital Investments, Inc., and an industry leader in the development of Computer-Aided Detection and image analysis software which assists radiologists in the early detection of disease, announces that on January 5, 2010 it received a further request for Additional Information letter from the US Food and Drug Adm
Novo Nordisk, a global healthcare company, announced the U.S. Food and Drug Administration approved the new drug application for Victoza, the first once-daily human glucagon-like peptide-1 analog for the treatment of type 2 diabetes.
Novo Nordisk announced the U.S. Food and Drug Administration approved the new drug application for Victoza, the first once-daily human glucagon-like peptide-1 analog for the treatment of type 2 diabetes.
Novo Nordisk announced the U.S. Food and Drug Administration approved the new drug application for Victoza, the first once-daily human glucagon-like peptide-1 analog for the treatment of type 2 diabetes. Victoza was evaluated in The Liraglutide Effect and Action in Diabetes phase III trials, the most comprehensive clinical development program con
02/08/10 Phadia, the world leader in allergy blood testing diagnostics, today announced that the United States Food and Drug Administration has cleared the ImmunoCAP Rapid Reader II, a part of the ImmunoCAP Rapid System, used to aid in the diagnosis of allergy in the physician's office.
SCHAUMBURG, Ill., Feb. 8Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that it has received FDA approval of labetalol hydrochloride injection, USP, commonly used to control severe hypertension.
Access Scientific has received FDA clearance for The PICC WANDTM, which enables clinicians to insert a peelable sheath for PICC or Midline catheter placement using the new Accelerated Seldinger Technique.
Abaxis, Inc., a medical products company manufacturing point-of-care blood analysis systems, announced that the U.S. Food and Drug Administration has granted 510K marketing clearance of the new C-Reactive Protein assay when used by healthcare professionals in conjunction with the Piccolo Xpress point-of-care analyzer.
Corventis, Inc., a developer of wireless cardiovascular solutions, announced that it has received 510 clearance from the US Food and Drug Administration to market its NUVANT Mobile Cardiac Telemetry System for the detection of non-lethal arrhythmias.
The federal Food and Drug Administration today approved a continuous-flow heart-assist device pioneered at the Texas Heart Institute at St. Luke's Episcopal Hospital for use as a permanent treatment for advanced heart failure. The approval of the pump device, the HeartMate II, follows several years of clinical trials and is seen as a major miles
The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as
A minimally invasive surgical approach developed by head and neck surgeons at the University of Pennsylvania School of Medicine has been cleared by the U.S. Food and Drug Administration. Drs.
