Approves in Biological Technology

EU Committee Approves New Food Applications for Martek's life'sDHA(TM)

COLUMBIA, Md., July 17 /PRNewswire-FirstCall/ -- DHA omega-3 innovator and maker of the life'sDHA(TM) brand of DHA, Martek Biosciences (Nasdaq: MATK ), announced today that it has received a unanimous positive vote from the Standing Committee On The Food Chain and Animal Health ...

EU Committee Approves New Food Applications for Martek's life'sDHA™

life'sDHA Now Approved for Use in Bakery Products, All Dairy Products, Cereal Bars, Beverages Columbia, MD (Vocus) July 16, 2009 -- DHA omega-3 innovator and maker of the life'sDHA ™ brand of DHA, Martek Biosciences, announced today that it has received a unanimo...

Photos: FDA Approves 12-Month Labeling Update for EVOLENCE(R) Collagen-Based Facial Filler

First and Only Collagen-Based Filler Proven To Last Through One Year HERZLIYA, Israel and SKILLMAN, N.J., June 8 /PRNewswire/ -- Ortho Dermatologics today announced that the U.S. Food and Drug Administration (FDA) approved a labeling supplement which includes efficacy and safety data through ...

FDA Approves Labeling Change for VYVANSE(R) (lisdexamfetamine dimesylate) CII to Include Supplementary Clinical Data Supporting Efficacy at 13 Hours Postdose in Children Aged 6 to 12 with ADHD

ADHD symptom control demonstrated from the first time point measured (1.5 hours) through 13 hours postdose PHILADELPHIA, June 1 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, Nasdaq: SHPGY ), the global specialty biopharmaceutical company, today announced that the US Food and Drug Adminis...

FDA Approves Boston Scientific's Next-Generation TAXUS(R) Liberte(R) Atom(TM) Stent System

NATICK, Mass., May 27 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced it has received approval from the U.S. Food and Drug Administration (FDA) to market its TAXUS(R) Liberte (R) Atom(TM) Paclitaxel-Eluting Coronary Stent System, a highly deliverable, next-g...

Arpida Annual General Meeting of Shareholders Approves All Board Proposals

REINACH, Switzerland, May 7 /PRNewswire-FirstCall/ -- The Annual General Meeting of Arpida Ltd (SIX: ARPN) has approved the proposals that were put forward by the Board of Directors. A total of 90 shareholders were present at the meeting that took place in Reinach today. 4,629,711 share...

Health Canada Approves SIMPONI(TM) (golimumab) for Treatment of Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis

Canadian Approval Is World's First Regulatory Approval for SIMPONI HORSHAM, Pa. and KENILWORTH, N.J., April 13 /PRNewswire-FirstCall/ Centocor Ortho Biotech Inc. and Schering-Plough Corporation (NYSE: SGP ) today announced that Health Canada has granted approval of SIMPONI (TM) (go...

FDA Approves Label Change for Non-Invasive Fibroid Treatment

TIRAT CARMEL, Israel, April 7 /PRNewswire/ -- InSightec Ltd. announced today that the U.S. Food and Drug Administration (FDA) approved a label change for the company's ExAblate(R) 2000 MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with non-hysteroscopically resectable...

FDA Approves SyntheMed's REPEL-CV(R) Adhesion Barrier for Use in Pediatric Cardiac Surgery

ISELIN, N.J., March 9 /PRNewswire-FirstCall/ -- SyntheMed, Inc. (OTC Bulletin Board: SYMD), a biomaterials company engaged in the development and commercialization of anti-adhesion products, today announced that the U.S. Food and Drug Administration (FDA) has approved the Pre-market Approval (PMA)...

FDA Approves SYMBICORT(R) for Chronic Obstructive Pulmonary Disease (COPD)

SYMBICORT provides a new, fast-acting(1) combination treatment option for millions of Americans with debilitating lung disease WILMINGTON, Del., Feb. 27 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN ) today announced that the U.S. Food and Drug Administration (FDA) has approved SYMBICO...

FDA Approves Apidra(R) SoloSTAR(R) - a Prefilled Disposable Insulin Pen

- Apidra(R) SoloSTAR(R) is a Convenient Insulin Delivery Device to Help Patients with Diabetes Improve Glycemic Control BRIDGEWATER, N.J., Feb. 26 /PRNewswire-FirstCall/ -- Sanofi-aventis announced today that the U.S. Food and Drug Administration (FDA) approved Apidra(R) SoloSTAR(R) (insulin ...

European Commission Approves EFIENT(R) (prasugrel) for Patients with Acute Coronary Syndrome Undergoing PCI

TOKYO and INDIANAPOLIS, Feb. 23 /PRNewswire-FirstCall/ -- Heart patients with acute coronary syndrome (ACS) undergoing an artery-opening procedure will soon have a new treatment option to help prevent heart attacks. Daiichi Sankyo Company, Limited (TSE: 4568) and Eli Lilly and Company (NYSE: LL...

Encouraging high-risk research: DFG approves funding for 2 new Reinhart Koselleck projects

The Deutsche Forschungsgemeinschaft (DFG, German Research Foundation) has announced that it will fund two new especially innovative and high-risk research projects. The Joint Committee of Germany's largest research funding organisation, located in Bonn, has approved funding for two new Reinhart Ko...

FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout

First new treatment option in more than 40 years, marking second FDA approval for Takeda within one month DEERFIELD, Ill., and OSAKA, Japan, Feb. 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced tod...

FDA Approves Clinical Studies of a Novel Anti-Cancer Drug Developed by Italian Researchers

NERVIANO, Italy, February 10 /PRNewswire/ -- - Nerviano Medical Sciences (NMS): Green Light From the FDA for the CDC7 Inhibitor Nerviano Medical Sciences (NMS) has secured Food and Drug Administration (FDA) approval to conduct for the first time clinical trials of a novel antitum...

FDA Approves KAPIDEX(TM) (Dexlansoprazole) delayed release capsules for the Treatment of GERD

First proton pump inhibitor (PPI) with a Dual Delayed Release(TM) (DDR) formulation DEERFIELD, Ill., and OSAKA, Japan, Jan. 30 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., today announced that the U.S. Food ...

Bion Announces PENNVEST Board Approves $7.8 Million Financing for Kreider Farms Dairy Project

NEW YORK, Jan. 28 /PRNewswire-FirstCall/ -- Bion Environmental Technologies, Inc. (OTC Bulletin Board: BNET) announced today that on Monday, January 26, 2009, the Pennsylvania Infrastructure Investment Authority (PENNVEST) approved a $7.8 million loan to Bion PA 1, LLC (a wholly-owned subsidiary...

Monsanto Board Approves 10 Percent Dividend Increase

ST. LOUIS, Jan. 14 /PRNewswire-FirstCall/ -- As the latest step in its ongoing commitment to return value to shareowners, Monsanto Company (NYSE: MON ) today announced that its Board of Directors declared a 10 percent increase in the quarterly dividend on its common shares from 24 cents per ...

FDA Approves Most Comprehensive System to Test Donated Blood for HIV, Hepatitis B & Hepatitis C

PLEASANTON, Calif., Dec. 31 /PRNewswire/ -- The United States Food & Drug Administration (FDA) today approved a new nucleic acid test from Roche to screen donated blood for HIV-1 Group M RNA, hepatitis C RNA and hepatitis B DNA in a single, automated assay. The test, called the cobas TaqSc...

MultiVu Video Feed: U.S Food and Drug Administration (Fda) Approves Latisse(TM) --

First and Only Treatment Approved by the Fda For Hypotrichosis of Eyelashes The U.S. Food and Drug Administration (FDA) has approved LATISSE(TM) (bimatoprost ophthalmic solution) 0.03% as a novel treatment for hypotrichosis of the eyelashes. Eyelash hypotrichosis is another name for ha...

FDA Approves Boston Scientific's Express(R) SD Renal Stent System

NATICK, Mass., Dec. 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced that the U.S. Food and Drug Administration (FDA) has approved the Express(R) SD Renal Monorail(R) Premounted Stent System for use as an adjunct to PTRA (percutaneous transluminal renal ang...

AUDIO from Medialink and GlaxoSmithKline: FDA Approves Boostrix for Adults

NEW YORK, Dec. 11 /PRNewswire/ -- Many adults may be familiar with the tetanus and diphtheria booster shot they get from their healthcare providers. Here's more about a booster shot that protects adolescents and adults from whooping cough, in addition to those diseases. Listen to this repo...

FDA Approves Boston Scientific's Apex(TM) PTCA Dilatation Catheter

New design provides more options for treating patients with complex lesions NATICK, Mass., Nov. 10 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX ) today announced that it has received approval from the U.S. Food and Drug Administration to market its Apex(TM) PTCA(1) Dilatat...

FDA Approves Ranexa(R) for First Line Anti Anginal Use and Adds New Claims for Reduction of Ventricular Arrhythmias, Bradycardia, New Atrial Fibrillation and HbA1c

- New labeling reinforces strong safety profile of Ranexa - - Conference call scheduled for 8:00 a.m. ET/5:00 a.m. PT - PALO ALTO, Calif., Nov. 6 /PRNewswire-FirstCall/ -- CV Therapeutics, Inc. (Nasdaq: CVTX ) announced today that the U.S. Food and Drug Administration (FDA) has approved a ...

FDA Approves Additional Indication for Norditropin(R) for Small for Gestational Age (SGA) in Children

Treatment Shown to Help Children Reach Normal Height PRINCETON, N.J., Nov. 4 /PRNewswire-FirstCall/ -- Children born with a condition that can prevent them from growing to a normal height now have a new treatment option available with the approval of Norditropin(R) (somatropin [rDNA origin] ...

FDA Approves Duramed's LoSEASONIQUE(R) Oral Contraceptive

Duramed to Launch First Lower-Dose, Extended-Cycle Oral Contraceptive for the Prevention of Pregnancy MONTVALE, N.J., Oct. 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL ) today announced that the U.S. Food and Drug Administration (FDA) has approved its subsidiary Durame...

FDA Approves Astellas' Vaprisol(R) (Conivaptan Hydrochloride Injection) Premixed in 5% Dextrose for the Treatment of Hyponatremia

Arginine vasopressin (AVP) receptor antagonist now approved in single-use premixed formulation DEERFIELD, Ill., Oct. 22 /PRNewswire/ -- Astellas Pharma US, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new premixed formulation of V...

FDA Approves Orphan Drug Status for Revolutionary Cancer Drug for Children

LOS ANGELES, Oct. 20 /PRNewswire/ -- The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced today that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ew...

FDA Approves AstraZeneca's SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania

WILMINGTON, Del., Oct. 10 /PRNewswire-FirstCall/ -- AstraZeneca (NYSE: AZN) today announced that the U.S. Food and Drug Administration (FDA) has approved once-daily SEROQUEL XR(R) (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with ...

FDA Approves Fougera's Clotrimazole Cream USP 1%

MELVILLE, N.Y., Sept. 12 /PRNewswire/ -- Fougera, a division of Nycomed US Inc., today announced the FDA has approved its Clotrimazole Cream USP 1%. The generic formulation compares to Taro's Referenced Listed Drug (RLD) and is available in three sizes: 15g tubes (NDC # 0168-0133-15), 30g tube...

FDA Approves ALOXI(R) (Palonosetron HCl) Capsules for Prevention of Acute Chemotherapy-induced Nausea and Vomiting

WOODCLIFF LAKE, N.J., Aug. 23 /PRNewswire/ -- Eisai Corporation of North America and its partner Helsinn Healthcare SA today announced that the U.S. Food and Drug Administration (FDA) has approved a new oral formulation of ALOXI(R) (palonosetron hydrochloride) for the prevention of chemotherap...

USDA Approves Syngenta and John Deere for Broadened Biotechnology Endorsement for Corn Crop Insurance

WASHINGTON, Aug. 19 /PRNewswire-FirstCall/ -- Syngenta Seeds, Inc. and John Deere Risk Protection, Inc. announced today that the U.S. Department of Agriculture's Federal Crop Insurance Corporation (FCIC) has approved Syngenta Agrisure(R) and other approved biotech corn seed brands for a broade...

Signalife Board Approves Merger

LOS ANGELES and LONDON, July 11 /PRNewswire-FirstCall/ -- Signalife, Inc. (Amex: SGN ) announced that it has received board approval to proceed with its previously-announced merger or similar business combination with Heart One Global Research, and that a specially-formed committee has been a...

FDA Approves EOVIST(R) to Detect and Characterize Focal Liver Lesions

First Organ-specific MRI Contrast Agent Approved in the United States in More Than a Decade WAYNE, N.J., July 8 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc., a leader in diagnostic imaging, announced today that the U.S. Food and Drug Administration (FDA) has ...

FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent

XIENCE V, Only Drug Eluting Stent to Demonstrate Superiority Over Market-Leading Stent in Clinical Trials, Now Available in United States for Treatment of Coronary Artery Disease ABBOTT PARK, Ill., July 2 /PRNewswire-FirstCall/ -- Abbott today announced that the U.S. Food a...

FDA Approves ACIPHEX(R) (rabeprazole sodium) 20 mg for Short-Term Treatment of GERD in Adolescents

WOODCLIFF LAKE, N.J., June 30 /PRNewswire/ -- Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced today that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatme...

FDA Approves CONCERTA(R) (methylphenidate HCI) Extended-release Tablets for Treatment of ADHD (Attention Deficit Hyperactivity Disorder) in Adults

CONCERTA(R) now available for patients with ADHD ages 6 to 65 RARITAN, N.J., June 27 /PRNewswire/ -- ADHD is the most common emotional, cognitive and behavioral disorder treated in children(1), and according to the National Institute of Mental Health (NIMH), between 30 percent and 70 perc...

FDA Approves Quark IND for DGFi, an siRNA Therapeutic Based on Silence Therapeutics' Unique Proprietary Chemistry

Quark Pharmaceuticals to develop drug candidate for prevention and treatment of delayed graft function in kidney transplantation LONDON, June 25 /PRNewswire/ -- Silence Therapeutics plc (London AIM: SLN) today announces that the U.S. Food and Drug Administration (FDA) has approved a Qua...

Big Win for Biodiesel: ASTM Approves New Biodiesel Blend Specifications

Automakers, Fleets Encouraged by New Biodiesel Standards VANCOUVER, British Columbia, June 20 /PRNewswire/ -- The biodiesel industry is celebrating today following last night's final vote by the ASTM International D02 Main Committee to approve a trio of long-awaited ASTM specifications...

FDA Approves GlaxoSmithKline's AVODART(R) in Combination with Tamsulosin for the Treatment of Symptomatic Enlarged Prostate

PHILADELPHIA, June 19 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved AVODART (dutasteride) in combination with tamsulosin for the treatment of symptomatic enlarged prostate, a disease that affects half of all ...