Tag: "approval" at medical news

UNH launches 2nd spinout company with NIH grants

...of the lungs are affected. Hersman has secured FDA approval to test polarized xenon with MRI in humans. The testing is scheduled for later this year with Sam Patz, a collaborator at Brigham and Women's Hospital in Boston. "The pressure is on now," said Hersman. "The world has been waiting long enough for a di...

Invasive pneumonia and antibiotic resistance decreased after childhood vaccine introduced

...the March 5, 2005 issue of The Lancet. Following approval of the seven-valent pneumococcal conjugate vaccine for young children in the U.S. in February 2000, the vaccine was in general use in Atlanta by the end of 2000. Antibiotic resistance in pneumonia, after increasing steadily in Atlanta from 4.5 per 1...

Protecting human subjects focus of national FDA conference at UH

... devoted to exploring the FDA critical pathway for approval of new medical products while protecting human subjects, co-sponsored by the Food and Drug Administration and the University of Houston, will be held at UH April 21-22. One of only three annual conferences sponsored by the U.S. Department of Health...

GlaxoSmithKline receives unanimous favorable recommendation by FDA Advisory Committee for Boostrix

...vided a unanimous favorable recommendation for FDA approval of Boostrix," said Barbara Howe, M.D., vice president, Clinical Research and Development and Medical Affairs, Vaccines North America, GlaxoSmithKline. "If approved, Boostrix would add a pertussis component to the routine tetanus/diphtheria booster c...

SAM on the favorable recommendation by FDA Advisory Committee for Boostrix

...gious disease. "We look forward to the anticipated approval of Boostrix for adolescents," said Vaughn I. Rickert, Psy.D., immediate past president of the Society for Adolescent Medicine. "Pertussis is a serious and growing public health threat, with outbreaks occurring nationwide. Pertussis among teens may ...

Study says rare allergic reactions to drug-eluting stents may raise risk for heart attack

...rocess called restenosis. However, since their FDA approval in 2003, stents coated with sirolimus (a pharmaceutical agent that prevents excess tissue growth) have been shown to greatly reduce restenosis. But some people suffer from rare, allergic-type reactions to the sirolimus-eluting stents (SES). Accordi...

New substance that improves the photodetection of bladder cancer gains market approval

...l be sold under the name Hexvix. Photocure ASA won approval March 2 for market release of Hexvix in 26 European countries. Every year, nearly 200,000 cases of bladder cancer are reported in Europe and the United States. In the US alone, more than 2.5 million screenings take place every year. If caught early, ...

Pioneering nanosystems degree wins approval

The Louisiana Board of Regents granted final approval Thursday for Louisiana Tech (in Ruston, La.) to offer a nanosystems engineering degree program, the nation's first such undergraduate degree. Tech's new Bachelor of Science degree program will be implemented this fall. According to the National Nano...

UIC offers new weight loss surgery for obese teens

...ne 2001 for use in adults. It has not received FDA approval for use in teens. In the current trial, 50 patients ages 14 to 17 will be enrolled in a five-year study to look at weight loss and the long-term medical effects of weight loss after the LAP-BAND procedure. In addition to surgery, patients will receiv...

Medication helps alcoholics control drinking

...ontinents. The findings, along with the recent FDA approval of a similar drug called acamprosate, open the door to new treatment options for drinkers who aren't yet ready to face total abstinence. Naltrexone, which is not addictive, "should be accepted as a short-term treatment for alcoholism," say authors ...

Simpler blood thinning medication effective for preventing blood clots and stroke

...ving to withdraw drugs from the market, has denied approval of ximelagatran because of concerns about hepatotoxicity. However, this precaution concerning the risk of hepatotoxicity from ximelagatran must be balanced against the serious risk of discouraging, if not foreclosing indefinitely, any improvement in ...

New stroke-prevention drug unlikely to be cost-effective except in patients at high risk of bleeding

...pplication to the Food and Drug Administration for approval of the drug as an agent to prevent strokes in pati...on appeal the FDA's original ruling and again seek approval for the drug in the U.S....

US FDA grants full approval to DOXIL(R) following submission of phase III data

...ood and Drug Administration (FDA) has granted full approval to DOXIL (doxorubicin HCl liposome injection) for ...ch Products, L.P., originally received accelerated approval for refractory ovarian cancer in June 1999. As a result of the full approval, the product label for...

New surgical procedure could save millions

...sionate use" on this one patient, although general approval is anticipated by summer. Steve Sheng, Ph.D., OmniGuide's president and CEO said, "We at OmniGuide are excited to see our technology being used for the first time on a human patient. The medical community has waited for a flexible fiber to deliver C...

Canadian neurologist wins highest award as American Stroke Association honors five

... for Cerebrovascular Research efforts that led to approval of the drug tPA as the first treatment for acute stroke. As leader of the NINDS Clinical Trial Group, Marler is focusing on accelerating the translation of recent discoveries in neuroscience into treatments for all neurological diseases. Kontos, CEO...

New treatment rivals chemotherapy for lymphoma, U-M study finds

...sity) developed the Bexxar regimen, which received approval from the U.S. Food and Drug Administration in June 2003 to treat follicular non-Hodgkin's lymphoma after other treatments have failed. The newly published research involves Bexxar as a first-line treatment for this disease. Non-Hodgkin's lymphoma, t...

Reviparin effective in reducing risk of death after heart attack

...ion of the data, or in the preparation, review, or approval of the manuscript. Editorial: Simple Principles of Clinical Trials Remain Powerful In an accompanying editorial, Robert M. Califf, M.D., of Duke Clinical Research Institute, Durham, N.C., discusses the CREATE trials. "What does [the CREATE-ECLA] t...

Stem cells given in minimally invasive procedure improve heart function

...cessary institutional and government health agency approval and each patient provided informed consent. All 3...ug Administration and hope to receive the agency's approval to conduct a trial at the University of Pittsburgh that would involve giving stem cells to patients ...

New leukemia drug shows promise in overriding all Gleevec resistance

... models," said Reddy, who is currently seeking FDA approval to proceed with clinical trials. The drug is licensed to Onconova, Inc. "Our drug works just like Gleevec but by blocking another part of the BCR-ABL protein. It can be combined with Gleevec to create synergy and when patients become resistant to G...

Vioxx went mostly to patients who didn't need it, Stanford researcher says

...d. "I think people misunderstand the nature of FDA approval and the criteria used to allow drugs to enter the market." Stafford noted that nearly all drugs carry some risks, but physicians and patients are generally willing to use them if the likely benefits outweigh the harms. Many people, for instance, are ...

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