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Schering-Plough Announces U.S. Filing Of Mometasone Furoate/Formoterol Fumarate Combination For The Maintenance Treatment Of Asthma
Schering-Plough announced that a New Drug Application (NDA) for a fixed-dose combination of mometasone furoate and formoterol fumarate has been filed in the United States and accepted for review by the U.S. Food and Drug Administration (FDA). Schering-Plough is seeking marketing approval from the FDA of the mometasone furoate/formoterol fumarate combination for the maintenance treatment of asthma in patients 12 years of age and older.

Do ADHD Drugs Cause Sudden Death?
This week, a study came out that scared us big-time ... it suggests that children and teens who take stimulants like Ritalin for ADHD have an increased risk for sudden cardiac death. Our pediatrician weighs in.
News of the day
Despite Some Progress, Key Senators Say August Deadline A Longshot
One day after President Obama told lawmakers to speed up their pace, three key Finance Committee senators expressed doubts about meeting the President"s August deadline for passing a reform proposal, Politico reports. Sen. Kent Conrad, D-N.D., said he doesn"t "see how" his colleagues can confirm the new Supreme Court nominee, Sonia Sotomayor, and pass a health bill in the time left before the August recess.
Endocrinology

FDA Reviewing Preliminary Safety Information On Asthma Drug Xolair

The U.S. Food and Drug Administration announced that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma. Reviewers are looking for a possible association between patients who use Xolair and an increased risk of heart attack, abnormal heart rhythm, heart failure, and stroke. The possible association has been identified based on interim results from an ongoing study of Xolair known as Evaluating the Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma (EXCELS). The study is being conducted by the manufacturer, San Francisco-based Genentech Inc. An FDA Early Communication is available online. The Early Communication is in keeping with the FDA"s commitment to inform the public about its ongoing safety reviews of drugs. Once its review is completed, the FDA will communicate its findings and any resulting recommendations to the public. Until the evaluation is completed, health care professionals and patients should be aware that the agency is reviewing data that may suggest a risk of adverse events. The FDA is not advising a change in prescribing or use of the drug. U.S. Food and Drug Administration


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