MIT research that stops pain of needle jabs gets FDA approval
Fear of needles could become a thing of the past....... A painkilling device approved by the FDA Aug. 17 could offer relief to children and adults who hate the sharp stab of pain that comes with needles and IVs....... The medical device, called SonoPrep, uses an ultrasonic method created by MIT researchers to make skin temporarily more permeable. A painless 15-second treatment by the new device,...FDA approves VYTORIN, first and only to powerfully reduce LDL cholesterol through dual inhibition
WHITEHOUSE STATION and KENILWORTH, N.J., July 23, 2004 Merck/Schering-Plough Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved VYTORIN (ezetimibe/simvastatin) for the treatment of high LDL cholesterol (LDL-C) in patients with primary hypercholesterolemia or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. VYTORIN is the fir...Rutgers cancer prevention expert calls for FDA action to reduce colon cancer and osteoporosis
NEW BRUNSWICK/PISCATAWAY, N.J. — Rutgers veteran cancer prevention expert Harold Newmark knows how to simultaneously achieve a 20 percent reduction in colon cancer deaths and osteoporosis-related fractures. Now he's calling upon the U.S. Food and Drug Administration (FDA) to help make this happen. ... ...Newmark's call to action involves the simple addition of calcium and vitamin D t...Unique partnership between UH, FDA opens path for scientific exchange
HOUSTON, July 19, 2004 A partnership between the FDA and the University of Houston that puts the College of Pharmacy in the vanguard of developing new drugs and biomedical policy is being revised and expanded. ... ...Making their respective resources more available to one another, the University of Houston College of Pharmacy and the Food and Drug Administration are providing a path for science...AACR applauds FDA decision to create new office of oncology drug products
By creating a new Office of Oncology Drug Products (OODP), the U.S. Food and Drug Administration has taken a significant step toward speeding the delivery of new drugs for the treatment and prevention of cancer, according to the American Association for Cancer Research (AACR).... ... "We applaud this great news," said Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of AACR, the world's...FDA approves Raptiva (efalizumab) for chronic moderate-to-severe plaque psoriasis
South San Francisco, CA, and Berkeley, CA Genentech, Inc. (NYSE: DNA) and XOMA Ltd. (Nasdaq: XOMA) announced today that RAPTIVA (efalizumab) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of chronic moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. RAPTIVA is the first biologic therapy that i...Weizmann scientists invention moves forward: Cancer diagnosis technique gets FDA clearance
Rehovot, Israel--September 23, 2003-- Thanks to a diagnostic imaging technique that should soon be finding its way to medical establishments, many patients could be spared the pain and risk of biopsies. The technique, called 3TP, has recently received FDA clearance for use in the detection of breast and prostate cancer, and is slated for distribution as early as next year. It will enable doctors...Diadexus receives FDA marketing clearance for PLAC (TM) test
SOUTH SAN FRANCISCO, Calif. July 18, 2003 -- diaDexus, Inc., a privately held biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company marketing clearance for the PLAC test. This test is cleared as an aid in predicting an individual's risk for coronary heart disease (CHD), in conjunction with clinical evaluation and patient risk assessment....NPF says FDA approval of new psoriasis drug signals new era of care
PORTLAND, Ore., Jan. 31, 2003 The National Psoriasis Foundation issued a statement today in support of the Food and Drug Administration's (FDA) approval of the first biologic drug to treat psoriasis. The FDA has approved Biogen's alefacept (brand name Amevive) to treat moderate to severe psoriasis.... ..."The Food and Drug Administration's approval of Amevive, is a significant step forward for t...Leading cancer research organization urges FDA to speed approval of drugs for precancers
Boston, MA (October 15 2002) The American Association for Cancer Research (AACR) today called for the federal government to open a new front in the war on cancer by speeding the approval of agents that prevent and treat precancerous lesions when the link between these lesions and cancer is shown. The statement is being released in conjunction with AACR's first-ever annual Frontiers in Cancer P...FDA clears for market new diagnostic test for lupus
SEATTLE The U.S. Food and Drug Administration has cleared for market a new screening test for lupus developed by researchers at the Fred Hutchinson Cancer Research Center. The test is considered the first significant diagnostic breakthrough for systemic lupus erythematosis, or SLE, in more than four decades. ...The test is expected to pick up the 20 percent of SLE cases that previously fell thro...Baxter's HomeChoice Pediatric dialysis system receives market clearance from FDA
Children with chronic kidney disease now have safe and ...easy-to-use home-based treatment ... ...DEERFIELD, Ill., December 11, 2001 - Baxter Healthcare Corporation announced today it has received clearance from the U.S. Food and Drug Administration (FDA) to market its HomeChoice Pediatric automated peritoneal dialysis (APD) system for use with pediatric patients undergoing peritoneal dialysis...ABBOTT PARK, Ill., Aug. 6, 2001 Abbott Laboratories announced today it has received U.S. Food and Drug Administration (FDA) approval of a new seven-day indication for Biaxin(R) XL (clarithromycin extended-release tablets) for the treatment of mild-to-moderate community-acquired pneumonia (CAP) in adults. Biaxin XL is the once-daily formulation of Abbott Laboratories' widely prescribed, advanced.... .Montville, NJ, May 14, 2001 -- Berlex Laboratories, Inc., a U.S. affiliate of Schering AG, Germany (NYSE:SHR), announced today that the U.S. Food and Drug Administration (FDA) approved YASMIN (R) (drospirenone and ethinyl estradiol). YASMIN is a new, low-dose, monophasic oral contraceptive and the first and only birth control pill to contain the unique progestin, drospirenone. .YASMIN is th.... . . . . . . . MONTVILLE, N.J., May 8, 2001 The U.S. Food and Drug Administration (FDA) late yesterday cleared Campath (alemtuzumab) humanized monoclonal antibody for marketing as a treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL) who have been treated with alkylating agents and have failed fludarabine therapy. With this decision, Berlex Laboratories, Inc., the...UCB-Bioproducts to provide active pharmaceutical ingredient for FDA approved angiomax (bivalirudin)
. UCB-Bioproducts (UCB-Bio) today announced that it will provide commercial quantities of bivalirudin, the active pharmaceutical ingredient (API) for The Medicine Company's (NASDAQ: MDCO) Angiomax, a thrombin-specific anticoagulant initially indicated for patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA), which received U.S. Food and Drug Administrati...First FDA approved, non-drug treatment for high-blood pressure now available
. .Initial use of the medical device in the U. S. is only in the Chicago area . . A new medical device that can help lower blood pressure with no side effects is now available in the United States by prescription exclusively in the Chicago area. The device, called RespeRate, analyzes a patient's breathing, then creates sound patterns that guide the patient to through breathing exercises to l....Montville, NJ, December 6, 2000 Berlex Laboratories, Inc., the U.S. subsidiary of Schering AG, Germany (NYSE: SHR), announced today that the U.S. Food and Drug Administration (FDA) approved MIRENA(R) (levonorgestrel-releasing intrauterine system), a convenient, innovative contraceptive that is as effective in preventing pregnancy as tubal ligation (better than 99 percent) and lasts for five ye...Using new FDA regulations, Kellogg takes the lead in promoting heart-health benefits of folic acid
.WASHINGTON, DC April 4, 2000 -- Kellogg Company announced today that it will be the nation's first leading food manufacturer to communicate on many of its adult targeted cereals that "adequate intakes of folic acid, vitamins B6 and B12 may promote a healthy cardiovascular system.". ."We are pleased to launch the first major application of the Food and Drug Administration's new regulations conce...FDA mandate for folic acid fortification may decrease the incidence of Down syndrome
.Increasing folate levels in women prior to conception -- which could be achieved either through fortified foods, natural dietary sources, or vitamin.supplementation -- may reduce the incidence of Down syndrome, according to a study funded by the United States Food and Drug.Administration (US-FDA) Office of Women's Health. . .Down syndrome is a genetic condition usually caused by an error in chr....(Washington, August 23) The Council for Agricultural Science and Technology.(CAST), The Georgetown Center for Food and Nutrition Policy and The.International Food Information Council (IFIC) agree with Consumer Reports'.statement that, "There is no evidence that genetically engineered [biotech].foods on the market are not safe to eat." . .This is supported by other leading medical and nutrition.... Ever since gene therapy was introduced almost ten years ago, there's been.much apprehension about genes from the disabled viruses used in the therapies.inserting their own genetic material into a recipient's reproductive cells. The.fear is that viral DNA could reach sperm or egg cells and potentially the genome.of subsequent generations. Deciding on an acceptable level of this potential.inse...AAPS Co-Sponsors FDA Science Forum
.Alexandria, VA -- AAPS is co-sponsoring the 1998 FDA Science Forum "Biotechnology: Advances, Applications, and Regulatory Challenges," with FDA and the FDA Chapter of Sigma Xi at the Washington Convention Center in Washington, D.C., Dec. 8-9, 1998. . .The FDA Science Forum is open to the public and will bring FDA research and review scientists together with representatives of industry, academi...Henney To Address Attendees At FDA Science Forum
.Alexandria, VA -- The new FDA Commissioner, Dr. Jane Henney, will arrive at FDA in time to participate in the 1998 FDA Science Forum, co-sponsored by the American Association of Pharmaceutical Scientists (AAPS). Dr. Henney will discuss the importance of science in biotechnology regulation with FDA scientists and the external scientific community. .AAPS is co-sponsoring the 1998 FDA Science Foru...FDA Approves Hopkins-Designed Implants To Restore Lost Voices
.Johns Hopkins physicians have designed a series of implants that restore.bulk to weakened vocal cords, returning the power of speech to those who have.lost their voices from paralysis associated with throat cancers, strokes or.other conditions. The patented implants were approved by the U.S. Food and Drug.Administration in early spring. . The implants, shaped like the heads of tiny ha...