In a complex decision, a slim majority of the Supreme Court upheld the constitutionality of the Affordable Care Act.
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FDA has approved lorcaserin (Belviq, Arena Pharmaceuticals and Eisai) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients who are overweight or obese and have at least 1 weight-related comorbid condition. It is the first prescription weight-loss treatment approved by FDA in 13 years.
FDA issued a complete response letter for a New Drug Application for apixaban (Eliquis, Bristol-Myers Squibb) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
FDA issued a complete response letter regarding a supplemental New Drug Application for rivaroxaban (Xarelto, Janssen Research & Development) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome.
The Academy of Managed Care Pharmacy strongly favors the revisions of the Prescription Drug User Fee Act (PDUFA) that the US House of Representatives and the US Senate conference committee negotiated earlier this week and the House passed by voice vote on Wednesday.
Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation.
A participant-driven reinforcement program for diabetes self-management education can have a positive effect on self-care behaviors as well as metabolic and cardiovascular health, according to a study published recently in Preventing Chronic Disease.
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.
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.
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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.
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.
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