Rolover

The U.S. Food and Drug Administration today approved a new indication for Tasigna (nilotinib) for the treatment of a rare blood cancer when it is first diagnosed. The cancer, called Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML), is a slowly progressing blood and bone marrow disease linked to a genetic abnormality.

The U.S. Food and Drug Administration is warning consumers that Magic Power Coffee, an instant coffee product marketed as a dietary supplement for sexual enhancement, contains an active drug ingredient that can dangerously lower blood pressure.

The U.S. Food and Drug Administration today approved the first assay to detect both antigen and antibodies to Human Immunodeficiency Virus (HIV). This assay is approved for use as an aid in the diagnosis of HIV-1/HIV-2 infection in adults including pregnant women. It is also the first assay for use as an aid in the diagnosis of HIV-1/HIV-2 infection in children as young as two years old.

One year ago, President Obama signed the historic Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Each day, medical devices from renal dialysis machines to implantable defibrillators, help prevent, diagnose, treat, and monitor serious and life-threatening diseases. After taking years to develop, these devices then undergo a regulatory review process before entering the marketplace. It then takes even more time for them to be adopted into clinical practice and for patients to realize the benefits.

Anesthesiologist Sentenced on Health Care Fraud