
FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

FDA approved enzalutamide (Xtandi, Astellas Pharma U.S. Inc. and Medivation) to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone.

Growth hormone-releasing hormone has favorable effects on cognition in healthy older adults and those with mild cognitive impairment, according to a study published online in the August issue of the Archives of Neurology.

Aminoglycoside-loaded bone cement implants, frequently used in orthopedic surgery, may result in systemic effects that raise aminoglycoside serum concentrations and lead to acute kidney injury, according to a study published July 3 in The Annals of Pharmacotherapy.

Systemic corticosteroid monotherapy of prednisone is not effective for patients with acute rhinosinusitis, according to a study published in the August 7 issue of the Canadian Medical Association Journal.

Vitamin D deficiency in critically ill children may make them more vulnerable to severe illnesses, according to 2 studies that were published ahead of the September print issue of Pediatrics.

FDA issued a Drug Safety Communication on sildenafil (Revatio, Pfizer), following the observation in a long-term extension of a clinical trial in pediatric patients with pulmonary arterial hypertension of an increase in mortality with increasing Revatio dose.

Children with cystic fibrosis who are taking ivacaftor (Kalydeco) may be at potential risk for cataracts, according to an FDA notification.

FDA approved linaclotide (Linzess, Ironwood Pharmaceuticals and Forest) to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation in adults.

FDA has approved tbo-filgrastim (Sicor Biotech UAB, a member of Teva Corporation), or XM02 filgrastim, the first new granulocyte colony-stimulating factor to be approved in the United States in more than 10 years to reduce the time certain patients receiving cancer chemotherapy experience severe neutropenia.

FDA has approved everolimus tablets for oral suspension (Afinitor Disperz, Novartis), a new pediatric dosage form of the anti-cancer drug everolimus (Afinitor, Novartis) used to treat a rare brain tumor called subependymal giant cell astrocytoma.

FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

FDA has approved the supplemental New Drug Application for tapentadol extended-release tablets (Nucynta ER, Janssen), an oral analgesic taken twice daily, for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.

Long-term use of proton pump inhibitors (PPI) may not significantly influence the development of osteoporosis, according to a recent study published July 10 in The American Journal of Gastroenterology.

Higher starting doses of allopurinol to treat gout may increase the risk for allopurinol hypersensitivity syndrome, according to a study published in the August 2012 issue of Arthritis & Rheumatism.

The use of generic prescription drugs instead of their brand-name counterparts has saved Americans and the nation's healthcare system $1.07 trillion over 10 years ending in 2011, according to the results of a study commissioned by the Generic Pharmaceutical Association.

A National Diabetes Care Commission will be established if new legislation introduced in the US Senate is passed.

FDA has approved Watson’s lidocaine topical patch 5%, the first generic version of Lidoderm (Endo) for the relief of pain associated with post-herpetic neuralgia.

FDA has approved buprenorphine and naloxone (Suboxone, Reckitt Benckiser Pharmaceuticals) sublingual film in the 4-mg and 12-mg strengths for the maintenance treatment of dependence on prescription opioid painkillers and heroin.

FDA approved Mylan Pharmaceutical's 15-mg, 30-mg, and 45-mg pioglitazone hydrochloride tablets, the first generic version of Actos (Takeda), along with diet and exercise to improve blood glucose control in adults with type 2 diabetes.

FDA has placed a partial clinical hold on Idenix Pharmaceuticals' nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus.

A coalition of 37 doctors, researchers, and public health officials petitioned FDA on July 25 to tighten label restrictions for opioid analgesics in an effort to curb prescription drug abuse.

It’s important to put processes in place to be sure a patient’s medication list at discharge from the hospital is the same information that is provided to the primary care physician to avoid medication errors, a recent study reports.

FDA has approved a prescription fish oil formulation for the treatment of very high levels of triglycerides, according to Amarin, the New Jersey-based biopharmaceutical company that developed the product.

Antiretroviral therapy should be offered to all patients as soon as possible, regardless of CD4 cell count, according to new recommendations offered during the AIDS 2012: XIX International AIDS Conference.

FDA has issued a Drug Safety Communication concerning three children who died and one child who experienced a nonfatal but life-threatening case of respiratory depression after taking the pain-reliever codeine following tonsillectomy and/or adenoidectomy.

FDA has approved the influenza vaccine formulation for 6 manufacturers for the 2012-2013 flu season.

A new formulation of the widely prescribed painkiller OxyContin has led drug abusers to shift to heroin, according to research results reported as a letter to the editor in the July 12 issue of the New England Journal of Medicine.

An oral dose of modified-release tranexamic acid may offer an effective first-line therapy for patients with heavy menstrual bleeding, according to a recent study published online July 17 in The Annals of Pharmacotherapy.

Short-term hormone replacement therapy is a relatively safe treatment for healthy, recently postmenopausal women, according to a new consensus statement.

A recent Danish study found that exposure to the influenza A(H1N1)pdm09 vaccine during pregnancy was not associated with a significantly increased risk of major birth defects or preterm births.