June 30, 2006
ROCKVILLE, Md. - The FDA has approved a label revision for the antibiotic Ketek (telithromycin) warning of possible severe and sometimes fatal liver injury during or immediately following treatment with the drug.
June 29, 2006
ROCKVILLE, Md. - The FDA today granted accelerated approval to Sprycel (dasatinib) for adults with chronic myeloid leukemia who are intolerant to Gleevec (imatinib) or become resistant to it.
June 28, 2006
ROCKVILLE, Md. - The FDA has given Exelon (rivastigmine), already approved for treatment of mild-to-moderate Alzheimer's dementia, the added indication of mild-to-moderate Parkinson's dementia. It is the first agent approved for the Parkinson's condition.
June 16, 2006
ROCKVILLE, Md. ? The FDA said today that 580 automatic external defibrillators, a model known as AED20, are being voluntarily recalled by MRL, a division of Welch Allyn, because of a malfunction that could result in failure to resuscitate patients.
June 14, 2006
CHICAGO - The American Medical Association has crafted a radical proposed solution to the problem of Americans with no health insurance coverage.
June 12, 2006
ROCKVILLE, Md. - The FDA today approved Wellbutrin XL (bupropion extended release) for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD). It is the first drug approved for SAD.
June 12, 2006
CHICAGO, June 12 ? It is unethical for physicians to participate in interrogation of prisoners by the military or law-enforcement agencies, pronounced the AMA's Council on Ethical and Judicial Affairs (CEJA).
June 09, 2006
ROCKVILLE, Md. ? In the opening salvo of an FDA initiative to cleanse the market of unapproved drugs, the agency has ordered some 120 cough and cold medicines that contain carbinomoxamine off store shelves. The two approved carbinomoxamine-containing products can continue to be sold.
June 08, 2006
ROCKVILLE, Md. - The FDA today approved Gardasil (quadrivalent human papillomavirus [Types 6, 11, 16, 18] recombinant vaccine) for prevention of cervical cancer and for prevention of cervical, vulvar and vaginal pre-cancers caused by HPV types 16 and 18.
June 06, 2006
ROCKVILLE, Md. - The FDA has cleared the way for Tysabri (natalizumab), the multiple sclerosis drug, to go back on the market but under a special restricted distribution program.