Tag: "approval" at medical news

Joslin announces first international affiliate in Bahrain

... the land, the funding and the Bahraini government approval for the project. "Since the early 1990s, the Bahrain Ministry of Health's strategic plan has included a focus on diabetes treatment," said Mr. Kanoo. "This center will help Bahrain raise diabetes awareness and introduce cost-effective treatment stra...

Three months is too soon to judge a CML patient's response to Gleevec, researchers find

...e frontline therapy. Gleevec also earned the FDA's approval for use in children, the first new pediatric cancer drug treatment in more than a decade. Recent studies also have found Gleevec to be effective in treating hypereosinophilic syndrome, a rare and often fatal blood disorder....

Roche files marketing application for Avastin with European health authorities

...e first treatment of its kind." An application for approval of Avastin in metastatic colorectal cancer was filed with the US FDA in September and has been designated for priority review status. Results of the pivotal study of Avastin in advanced colorectal cancer were announced earlier this year and demonstra...

The evolving management of migraine

...s and insomnia. Topiramate is expected gain final approval as a migraine treatment in 2004. Another new type of treatment involves injection with botulinum toxin. This treatment is used for dystonia (involuntary movements) and spasticity, and has recently been shown to be an effective migraine preventive the...

New breast scanner can detect early signs of cancer

...hat with a dual imager." Tornai is awaiting patent approval on the new device, including the combination device that overlays X-ray and nuclear medicine images....

Freezing technique kills majority of small malignant breast cancers

... Inc., which has U.S. Food and Drug Administration approval for its Visica cryoablation system as a means of freezing benign breast masses called fibroadenomas. The technique is already in use in many states as an office-based, non-surgical means of treating benign breast disease, via a thin probe inserted i...

Wanted: people to test orgasmatron

...f the "orgasmatron" have begun in the US, with the approval of the Food and Drug Administration. The device was the focus of massive media attention two years ago, after New Scientist broke the news of its existence and used the term orgasmatron to describe it (10 February 2001, p 23).But despite all the cov...

PRAECIS PHARMACEUTICALS INC receives FDA approval for Plenaxis

...rostate cancer patients who are most in need. The approval of Plenaxis TM represents years of dedication to ...ed pharmaceutical company. More importantly, this approval will bring a valuable therapy to those patients in the indicated population who have limited or no o...

FDA approves Climara Pro to treat menopause symptoms

...nd Drug Administration (FDA) has granted marketing approval for Climara Pro®(estradiol/levonorgestrel) tra... symptoms that negatively impact their lives. FDA approval of a new, unique option lends credibility to the fact that hormone therapy remains an important and ...

Investigational drug brings new hope to kidney cancer patients

... which is still accruing patients, and to seek FDA approval based on those results compared to historical controls, or to design a new phase III trial. "It's a difficult issue," adds Stadler. "When you've got something exciting for a lethal disease like advanced cancer, how much evidence do you need?" "When ...

Microneedles: Report describes progress in new technology for painless drug delivery

...before they can receive Food & Drug Administration approval for clinical use. Before microneedles find widespread use, the researchers must perfect the techniques for optimally inserting them into the skin, and complete the integration of microneedles into a full drug delivery system. The need to minimize va...

Pfizer's VFEND(R) receives FDA approval for treatment of esophageal candidiasis

...s received U.S. Food and Drug Administration (FDA) approval to market VFEND (voriconazole), a broad spectrum ...ore serious, invasive disease. The basis for the approval of VFEND to treat esophageal candidiasis infections was a clinical trial with immunocompromised pati...

Low infection rate in Arrow Lionheart* European trial

...2001, Arrow announced that the device received FDA approval under the Investigational Device Exemption to begin Phase I human clinical trials. The first U.S. recipient of the LionHeart received the device on Feb. 28, 2001, at Penn State Milton S. Hershey Medical Center. On July 26, Penn State Hershey Medical ...

New technology offers quicker recovery, better results after vision-saving glaucoma surgery

.... The shunt received Food and Drug Administration approval in March 2002. So far about 700 ophthalmologists nationwide have trained to do the procedure, including about 50 in Texas. Conventional shunts used to treat glaucoma are larger, forcing ophthalmologists to make bigger cuts on the eye. Now, the incisi...

The statin wars: Why AstraZeneca must retreat

...r safety concerns, rosuvastatin finally won US FDA approval in August and was launched last month, winning a 2% market share after only three weeks. [Tom] McKillop [AstraZeneca's Chief Executive] has pledged to do whatever it takes to persuade doctors to prescribe rosuvastatin, including launching an estimate...

New drug for non-small cell lung cancer shows efficacy

... data fromthis clinical trial formed the basis for approval of the drug by theFood and Drug Administration on May 5, 2003. "This compound is the first new way to treat lung cancer in decades, andthis is good news," said Dr. Kris, lead investigator of the multi-centertrial. "It is what all people trying to fig...

Act now to secure Iraq's health

... also comments on progress being made, notably the approval by the US House Appropriations Committee of $100 million for funds to refurbish and modernise hospitals and primary-care services throughout Iraq: 'We trust that the House and Senate will support this sensible redistribution of funding for health. Su...

Iressa news backgrounder

...elped lead to federal Food and Drug Administration approval of the drug in early 2003 for use when standard th...ionwide trial - the one that eventually led to FDA approval of the drug - that showed Iressa shrank tumors in about 10 percent of lung cancer patients that were...

New drug reduces chemotherapy-induced nausea and vomiting

...e basis of the U.S. Food and Drug Administration's approval of aprepitant in March 2003. Aprepitant Combined with Standard Treatment for Nausea and Vomiting Helps Prevent These Symptoms Following Chemotherapy The first study, led by Paul J. Hesketh, MD, at the Caritas St. Elizabeth's Medical Center in Bos...

Astrazeneca receives European approval for Seroquel; in bipolar mania

...es with the FDA and in the UK with the MHRA. "This approval is great news for clinicians involved in the treatment of bipolar disorder," commented Dr. Eduard Vieta, Director of Research, Department of Psychiatry, University of Barcelona. "The results from the clinical trial programme confirm that SEROQUEL hol...

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