March 14, 2007
ROCKVILLE, Md -- The FDA has taken steps to ensure that clinicians and patients are aware of rare bizarre effects associated with sedative hypnotics, including driving or eating while sleeping.
March 13, 2007
ROCKVILLE, Md. -- The FDA today approved lapatinib (Tykerb), an oral kinase inhibitor that targets HER2-positive tumors, for treatment-refractory metastatic breast cancer, to be used in combination with capectabine (Xeloda).
March 09, 2007
ROCKVILLE, Md. -- For the second time in two weeks, the FDA has informed physicians of an excess fracture risk in women taking an oral diabetes drug in the thiazolidinedione class. This time the drug is pioglitazone (Actos).
March 08, 2007
ROCKVILLE, Md. -- More than 40,000 automatic external defibrillators in schools, health clubs, and other public sites have been recalled because of a potentially faulty low-battery signal, the FDA reported.
March 06, 2007
ROCKVILLE, Md. -- The FDA said today it has approved aliskiren (Tektuma), the first oral direct renin inhibitor for treatment of hypertension.
March 05, 2007
ROCKVILLE, Md. -- The FDA has licensed an automated nucleic acid test to screen donor blood for West Nile virus.
March 05, 2007
ROCKVILLE, Md. -- The FDA has warned about a norovirus outbreak linked to raw oysters harvested in San Antonio Bay, on the Texas Gulf coast north of Corpus Christi.
February 27, 2007
ROCKVILLE, Md. -- The FDA has approved lisdexamfetamine dimesylate (Vyvanse), formerly known as NRP104, for attention deficit hyperactivity disorder.
February 26, 2007
KISSISSIMEE, FLA. -- Escalated-dose conformal radiotherapy for localized prostate cancer was associated with a 34% reduction in the relative risk of biochemical failure in a randomized trial of 843 men also with treated with androgen deprivation therapy.
February 21, 2007
ROCKVILLE, Md. -- Anaphylaxis reports associated with the asthma drug omalizumab (Xolair) led the FDA today to order Genentech to add a black box warning to the agent's label.