Regulatory Affairs / Drug Approvals News From Medical News Today Latest Health News and Medical News posted throughout the day, every day.
FDA Approves Botox To Treat Spasticity In Flexor Muscles Of The Elbow, Wrist And Fingers
The U.S. Food and Drug Administration approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis...
FDA Clears biospace med's SterEOS 2D/3D Workstation For Pediatric Use In Spine
biospace med announced today that it has received 510(k) clearance from the FDA (Food and Drug Administration) to market the Company's sterEOS 2D/3D workstation for pediatric use in spine applications. The Company's EOS ultra-low-dose imager previously has been FDA-cleared for use in pediatrics and adults, while sterEOS has previously been FDA-cleared for adult use in spine...
ImmunoGen, Inc. Announces Orphan Drug Designation Granted To IMGN901 For Treatment Of Merkel Cell Carcinoma By US FDA And EU COMP
ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer products using its antibody expertise and Targeted Antibody Payload (TAP) technology, announced that the US Food and Drug Administration (FDA) has granted orphan drug designation to its IMGN901 compound when used for the treatment of Merkel cell carcinoma (MCC)...
Axis Surgical Technologies, Inc. Received 510(k) Clearance For The C-MOR(TM) Visualization Device
Axis Surgical Technologies, Inc., announced that it has received 510(k) clearance from the Food and Drug Administration to market their C-MORâ„¢ Visualization Device for use in diagnostic and operative arthroscopic and endoscopic procedures...
FDA Clears The Fenwal Amicus(R) Separator System For Collecting Platelets In New Additive Solution
Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced that the U.S. Food and Drug Administration has granted Fenwal 510(k) clearance to market its Amicus® blood cell separator for collecting human platelets stored in InterSol® platelet additive solution (PAS 3)...
ThermalTherapeutic Systems Announces FDA Clearance Of The VERATHERM(TM) Portable Hyperthermic Perfusion System
ThermalTherapeutic Systems, Inc. announced that the FDA has cleared the company to market its VERATHERMâ„¢ Portable Hyperthermic Perfusion System effective immediately...
MicroPhage Seeks FDA Clearance To Market World's First Test Designed To Rapidly Identify Bacterial Infections And Antibiotic Susceptibility
MicroPhage announced that it has submitted human data from a pivotal clinical study of its 'Microphage MRSA/MSSA Blood Culture Test' to support a U.S. Food and Drug Administration (FDA) 510(k) premarket notification process. The first of MicroPhage's instrument-free, rapid tests is based on the Company's patented Bacteriophage Amplification platform technology...
Salmonella In HVP Additive Prompts Potentially Massive Processed Food Recall
Thousands of types of processed foods containing hydrolyzed vegetable protein or HVP made by Basic Food Flavors Inc in Las Vegas, Nevada, may pose a health risk due to possible contamination with Salmonella Tennessee, said the US Food and Drug Administration last week...
Senators To FDA: Lift Ban On Gays Donating Blood
The Associated Press: "The time has come to change a policy that imposes a lifetime ban on donating blood for any man who has had gay sex since 1977, 18 senators said Thursday. ... The lawmakers stressed that the science has changed dramatically since the ban was established in 1983 at the advent of the HIV-AIDS crisis...
CSL Behring Receives FDA Approval Of HizentraTM, First 20 Percent Subcutaneous Immunoglobulin Therapy
CSL Behring announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for HizentraTM, Immune Globulin Subcutaneous (Human), 20% Liquid, for treating patients diagnosed with primary immunodeficiency (PI)...
InterMune Announces Posting Of Briefing Documents For FDA Advisory Committee Meeting On Pirfenidone
InterMune, Inc. (Nasdaq: ITMN) announced that the U.S...
Salmonella Tennessee Identified In A Processed Food Ingredient
The U.S. Food and Drug Administration is taking steps to protect the public following the early identification of Salmonella Tennessee in one company's supply of hydrolyzed vegetable protein (HVP). This is a common ingredient used most frequently as a flavor enhancer in many processed foods, including soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings...
FDA Approves Name Change For Heartburn Drug Kapidex
The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex (dexlansoprazole) to avoid confusion with two other medications - Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant...
Covidien Launches Oral Transmucosal Fentanyl Citrate Product
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that Mallinckrodt Inc., a Covidien company, has launched its Oral Transmucosal Fentanyl Citrate (CII) to distributors serving retail pharmacies across the country. The U.S...
Rexahn Pharmaceuticals Submits Zoraxel Phase IIb Protocol To FDA
Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company commercializing potential best in class oncology and CNS therapeutics, announced that it has submitted a Phase IIb protocol to the FDA for ZoraxelTM for the treatment of erectile dysfunction (ED). "The progression of Zoraxel's clinical program is very encouraging," said Rexahn Chief Executive Officer, Dr...
ImmuneRegen BioSciences Submits Homspera(R) For FDA Orphan Drug Product Designation For The Treatment Of Idiopathic Pulmonary Fibrosis
ImmuneRegen BioSciences Inc.®, a wholly owned subsidiary of IR Biosciences Holdings Inc. (OTCBB: IRBS), today announced the submission of an application for Orphan Drug Product Designation for the company's lead compound, Homspera®, for the application of treating Idiopathic Pulmonary Fibrosis, a deadly pulmonary disease with no FDA-approved treatments...
Tantaline Gains Approval From FDA
Tantaline®, the world's leading producer of surface alloys for valves, fittings, instrumentation, and custom products in highly corrosive and/or hot acid environments, announced that it has been approved for use by the U.S. Food and Drug Administration (FDA). The FDA approval was granted to Tantaline's tantalum surface alloy material...
Three Harvard School Of Public Health Alumni Named To New FDA Tobacco Advisory Committee
The recently formed Food and Drug Administration (FDA)'s Center for Tobacco Products has just created a new Tobacco Products Scientific Advisory Committee to review and evaluate safety, dependence, and health issues relating to tobacco products and provide appropriate advice, information, and recommendations to the Commissioner of Food and Drugs...
FDA Warns Consumers In Puerto Rico Of Harmful Bacteria In Hand Sanitizers
The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers - "Bee-Shield Hand Sanitizer" with Aloe Vera (10 fl. oz. or 1 gallon bottles) and "MD Quality Hand Sanitizer" with Aloe Vera (10 fl oz. bottles) - contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans...
FDA, FSIS, CDC Collaborate On Methods To Measure Success Of Food Safety Programs
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) will host a joint public workshop on how best to measure progress in reducing foodborne illnesses on March 30, in Washington, D.C...
FDA Provides 510k Clearance For BARRX Medical's HALO90 Ablation Catheter For The Treatment Of Radiation Proctitis And Gastric Antral Vascular Ectasia
BARRX Medical, Inc. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its HALO90 Ablation Catheter for the treatment of Radiation Proctitis (RP) and Gastric Antral Vascular Ectasia (GAVE). Both conditions are diseases of the gastrointestinal tract associated with chronic bleeding and the need for blood transfusions...
Novo Nordisk Receives FDA Approval For Norditropin® FlexPro® For Growth Hormone Treatment
Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Norditropin® FlexPro® (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children and adults with growth hormone disorders. It will be available in the second quarter...
FDA Approves Exalgoâ„¢ Extended-Release Tablets
CombinatoRx, Incorporated (NASDAQ: CRXX) announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Exalgoâ„¢ (hydromorphone HCl) extended-release tablets, for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time...
FDA Calls On Food Companies To Correct Labeling Violations; FDA Commissioner Issues An Open Letter To The Industry
The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act. The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg, M.D...
FDA Classifies Baxter's January HomeChoice Peritoneal Dialysis Cycler Field Corrective Action As A Class I Recall
Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has classified Baxter's recent Urgent Product Recall regarding Increased Intraperitoneal Volume (IIPV), or overfill of the abdominal cavity, associated with HomeChoice and HomeChoice Pro peritoneal dialysis cyclers as a Class I recall...
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