FDA approved the first generic versions of montelukast sodium (Singulair, Merck) for use in adults and children to control asthma symptoms and to help relieve symptoms of indoor and outdoor allergies.
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Iron supplementation 2 to 3 times a week may prevent anemia in pregnant women as well as daily supplementation, according to a recent Cochrane systematic review published online July 11.
FDA approved a new REMS for extended-release and long-acting opioids, which is expected to affect more than 20 companies that manufacture opioid analgesics.
A new study has found that omega-6 poly-unsaturated fatty acids can help prevent coronary heart disease (CHD) and that dietary saturated fat increases the risk for CHD.
Patients with atrial fibrillation who are admitted on the weekend are less likely to receive cardioversion procedures and more likely to die than those who are admitted during the week, according to a new study published in the July 15 issue of The American Journal of Cardiology.
The passage of the FDA Safety and Innovation Act will support innovation, answer the current shortages, and even regulate mobile applications.
New molecular entity: FDA approved taliglucerase alfa (Elelyso, Pfizer), a recombinant active form of the glucocerebrosidase enzyme for long-term enzyme replacement therapy (ERT) for adults with type 1 Gaucher disease.
New formulation: FDA approved pancrelipase delayed-release capsules (Pertyze, Digestive Care, Inc.) for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
The Institute of Medicine reports that a number of issues are causing a number of barriers to successful HIV care in the United States.
Atrial fibrillation(AF) is the most common sustained cardiac arrhythmia and a potent risk factor for stroke. Here's a review of new oral anticoagulants for stroke prevention with AF.
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The introduction of the immunomodulatory drugs and bortezomib, a proteasome inhibitor, has dramatically improved outcomes in patients with relapsed or refractory multiple myeloma.
Screening for hepatitis-C may soon become a routine screening for Baby Boomers.
A new study seems to indicate that adding cetuximab to the standard therapy for resected stage 3 colon cancer provides no additional benefits.
Recent FDA action (through July 2012) related to, morphine and oxycodone Dual Opioid platform, MoxDuo, QRxPharma, apixaban, Eliquis, Bristol-Myers Squibb, RG1068, Repligen, Multi-Stem, Athersys, Rivaroxaban, Xarelto, Janssen, Ocriplasmin intravitreal injection, ThromboGenics, Regorafenib, Bayer, Onyx Pharmaceuticals, Pregabalin, Lyrica, Lupin, Diclofenac sodium and misoprostol, Arthrotec, Watson, Next Choice One Dose, Plan B One-Step
The FDA recently announced a safety communication regarding the risk of seizures with MS who are starting dalfampridine.
A recent study from JAMA indicates that most Americans aren't meeting the necessary goals to lower CV risks.
Recent FDA Approvals (through July 2012) related to (Vivus, Gilead Sciences, Orasure, Pfizer, Ferring Pharmaceuticals, Eli Lilly, Bristol-Myers Squibb, Qiagen, Astellas Pharma US, Roche Molecular Systems, Arena Pharmaceuticals, Eisai)
A review of drug therapies and research presented at the 2012 Scientific Session of the American Diabetes Association.
FDA has approved prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
In a unanimous vote (10-0), an FDA advisory committee recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech, a member of the Roche Group) for treatment of diabetic macular edema.
FDA is ridding the market of single-ingredient oxycodone capsules and oral liquids that are being distributed without an FDA-approved application.
A recent study in Cancer Research suggests that modest caffeine consumption may be associated with a significantly lower relative risk of basal cell carcinoma.
The Centers for Disease Control and Prevention recently updated its 1991 recommendations for the management of hepatitis B virus (HBV)-infected healthcare providers and students to prevent HBV transmission to patients.
The Two Sister Study, funded in part by Susan Komen for the Cure, was conducted to examine the possible risks associated with fertility drugs and breast cancer. The results were published July 6 in the Journal of The National Cancer Institute.
To reduce the money spent on treatments that don't work, health plans and payers are examining closely how Comparative Effectiveness Research (CER) can steer patients and providers to more appropriate care. This approach is gaining momentum from the Patient Centered Outcomes Research Institute (PCORI), which is poised to distribute some $120 million in coming months—and nearly $400 million in 2013—to launch a range of CER projects.
FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
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