USFDA

United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen launched by Medicure Inc, a specialty pharmaceutical company. Aggrastat is Antiplatelet drug. It is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome (NSTE-ACS).

Syneron Medical Ltd. (NASDAQ: ELOS), a global market leader in the aesthetic medical device marketplace, announced today that the PicoWay® picosecond laser received U.S. Food and Drug Administration (FDA) clearance for the treatment of pigmented lesions.

AstraZeneca, a global, innovation-driven biopharmaceutical business,  announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the MEK inhibitor selumetinib, for the treatment of uveal melanoma.

Sandoz, a global leader in generic pharmaceuticals and a  subsidiary of Novartis, has received approval from the US Food and Drug Administration (FDA) for Glatopa. Glatopa is the first FDA-approved, substitutable generic version of Copaxone^® 20mg, a treatment for relapsing forms of multiple sclerosis. Sandoz, together with Momenta, is proud to be the first company to receive FDA approval for a substitutable generic version of this important therapy.

The US Food & Drug Administration (FDA) has granted Fast Track designation to Exelixis, Inc's cabozantinib for treatment of patients with advanced renal cell carcinoma (RCC). Cabozantinib is the Exelixis' lead compound . Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer.

Ethicon, a part of J&J, received expanded FDA indication for its EVARREST Fibrin Sealant Patch to be used to help control bleeding during adult liver surgeries. The device is bioabsorbable and contains human thrombin and fibinogen proteins that participate in clot formation. It retains its strength and stickiness while it’s still around. EVARREST is a novel convergence of biologics and medical device that rapidly and reliably stops problematic bleeding during surgery on the first attempt in indicated patients. EVARREST is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis . The unmatched mechanism of action behind EVARREST drives rapid and durable clot formation. The technology is comprised of a flexible composite patch, which contains embedded human biologics (human thrombin and fibrinogen), which are proteins involved in the natural clotting process.

Gilead Sciences has submitted a new drug application (NDA) to the FDA for two doses of an investigational fixed-dose combination of emtricitabine and tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults and pediatric patients aged 12 years and older, in combination with other HIV antiretroviral agents.

Oncolytics Biotech Inc., a biotechnology company concentrated on the development of oncolytic viruses as potential cancer therapeutics. Company has presented an application to the US Food and Drug Administration (FDA) for REOLYSIN to get Orphan Drug Designation for the treatment of gastric cancer.

The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug “Feraheme”. It could cause potentially life-threatening allergic reactions. The drug — approved for use only in adults with chronic kidney disease who have iron-deficiency anemia — has been contraindicated also in patients with known hypersensitivity to ferumoxytol or any of its components or a history of allergic reaction to any intravenous iron product. Health care professionals should strictly follow the recommendations mentioned in the drug label. Patients should immediately call doctor if there is breathing problems, low blood pressure, lightheadedness, dizziness, swelling, a rash, or itching during or after Feraheme administration.

The U.S. Food and Drug Administration approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test for the treatment of delayed gastric emptying, known as gastroparesis. Gastroparesis is a condition in which your stomach cannot empty itself of food in a normal fashion. It is caused by damage to the vagus nerve, which regulates the digestive system. A damaged vagus nerve prevents the muscles in the stomach and intestine from functioning, preventing food from moving through the digestive system properly. If this left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.