Injections of methotrexate were not superior to oral therapy in long-term treatment of patients with juvenile idiopathic arthritis, according to a new study, published in the May 30 online edition of Arthritis Care & Research.
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A combination of 2 diabetes drugs, metformin and rosiglitazone (Avandia, GlaxoSmithKline), was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a study funded by the National Institutes of Health has found.
House and Senate leaders announced final agreement June 18 on legislation that authorizes industry user fees to support FDA regulatory programs.
Republicans in the House of Representatives have published a report blaming the current increase in drug shortages mostly on FDA under the current administrator.
FDA has approved the first combination vaccination for use in children aged 6 weeks through 18 months for the prevention of invasive disease caused by Neisseria meningitidis serogroups C and Y and Haemophilus influenza type b, according to an FDA statement.
Men with advanced prostate cancer treated with investigational enzalutamide (formerly MDV3100) demonstrated a significantly higher response rate in health-related quality of life compared with placebo, according to new data from the phase 3 AFFIRM study.
Investigational afatinib used in non-small cell lung cancer treatment helped patients live longer compared with pemetrexed/cisplatin, according to the results of a new phase 3 clinical trial.
Nonsteroidal anti-inflammatory drugs may prevent the development of skin cancer, according to a new study, published online first in the journal Cancer on May 29.
In a recent study, researchers find reasons why a significant number of US adults are at risk of unintentionally overdosing on over-the-counter pain medications.
Daily vitamin D (≤400 IU) and calcium (1,000 mg) supplements for the primary prevention of fractures in postmenopausal women are no longer recommended as they don’t help prevent fractures and may cause harm, according to draft guidance from the US Preventive Services Task Force.
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FDA has approved pertuzumab (Perjeta, Roche) in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
FDA has approved gabapentin enacarbil (Horizant, GlaxoSmithKline and XenoPort) extended-release tablets for the management of postherpetic neuralgia in adults.
The industry should collaborate to develop a US Biopharmacopeia Registry of Biopharmaceutical Products to help resolve biosimilar and broader biopharmaceutical nomenclature issues, according to a leading author and publisher.
Intensive control of blood-sugar levels among patients with type 2 diabetes mellitus may reduce the risk of microalbuminuria and macroalbuminuria, signs of kidney damage, but evidence is lacking regarding the effect over renal end points, according to the results of a study published May 28 in Archives of Internal Medicine.
The Centers for Medicare and Medicaid Services is partnering with providers, caregivers, and patients to ensure appropriate use of antipsychotic medications for nursing home patients, the government announced last week.
The Centers for Disease Control and Prevention is proposing an expansion of its current hepatitis C risk-based guidelines to include a simple, one-time blood test for anyone born from 1945 through 1965.
Sandoz, a division of Novartis, is voluntarily recalling 10 lots of its generic oral contraceptive Introvale (levonorgestrel and ethinyl estradiol) tablets in the United States, after a consumer reported a packaging flaw.
The Health Data Initiative Forum III: The Health Datapalooza cohosted by the Institute of Medicine and the US Department of Health and Human Services (HHS) is convening this week in Washington, DC, focusing on innovative applications and services that harness the power of open data from HHS and other sources to help improve health and healthcare.
Legislation to reauthorize FDA user fee programs sailed through the House and Senate last month, setting the stage for leading legislators to resolve their differences and agree on a compromise measure. Much of the work will be tackled by committee staffers who have been laboring over the legislative details for months. The aim is to bring the House and Senate leaders together in about 2 weeks to hash out the final language.
The number of physicians and clinicians using e-prescribing increased by 67% in 2011 and they filled 75% more medication orders electronically, according to a new downloadable report by Surescripts, which operates a nationwide network connecting the computer systems of physicians and pharmacies.
Folic acid fortification of US grain products may be lowering rates of certain kidney and brain cancers in children but does not appear to be causing childhood cancer rates to increase, according to findings from a study published online May 22 in the journal Pediatrics.
Statin therapy is safe and effective for people at low risk of major vascular events and, therefore, current guidelines might need to be reconsidered, according to a study published online in The Lancet.
More than a third of patients newly diagnosed with type 2 diabetes mellitus did not receive the recommended first-line drug, a finding that could have substantial implications for healthcare spending, according to a study published in the American Journal of Medicine.
Changes in procedural antithrombotic strategy are associated with a significant temporal reduction in major bleeding over time in patients undergoing elective post-percutaneous intervention, according to a study published in the Journal of the American College of Cardiology.
New molecular entity: FDA approved lucinactant (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants at high risk of RDS.
FDA recently issued a warning about an increased risk of developing new cancers for patients taking lenalidomide (Revlimid, Celgene) for the treatment of multiple myeloma.
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