FDA has approved a change to the prescribing information for ambrisentan 5-mg and 10-mg tablets (Letairis, Gilead Sciences) once-daily treatment to improve exercise ability and delay clinical worsening in patients with pulmonary arterial hypertension (PAH, WHO Group 1) and predominantly WHO Functional Class II-III symptoms.
The risk of certain birth defects is higher in women given opioid analgesics such as hydrocodone during pregnancy, according to a new study.
FDA recently announced its plans to remove certain unapproved prescription medicines used to treat cough, cold, and allergy symptoms.
Children aged 6 to 23 months who receive trivalent inactivated flu vaccine concurrently with the 13-valent pneumococcal conjugate vaccine are at increased risk of febrile seizures, according to researchers at the Centers for Disease Control and Prevention in Atlanta and Harvard Medical School in Boston.
The angiogenesis inhibitor bevacizumab, used with chemotherapy or biological therapy, carries an increased risk of treatment-related death in cancer patients compared with chemotherapy alone, a new study shows.
The anticancer drug bevacizumab could help prevent babies with retinopathy of prematurity from becoming blind, reports a new study from the University of Texas Health Science Center at Houston Medical School.
FDA has updated the pregnancy section of drug labels for the entire class of antipsychotic medications to provide more information about the potential risk of extrapyramidal signs and withdrawal symptoms in newborns whose mothers take antipsychotics during the third trimester of pregnancy.
FDA's Pulmonary-Allergy Drugs Advisory Committee voted to approve Novartis' QAB149 (indacaterol) 75 µg as a once-daily long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, including chronic bronchitis and/or emphysema, PR Newswire reported.
The American College of Physicians recently issued 3 recommendations for use of intensive insulin therapy for the management of glycemic control in hospitalized patients.
FDA approved the first-and-only selective phosphodiesterase type 4 inhibitor roflumilast (Daliresp, Forest Pharmaceuticals), once-daily oral tablet to decrease the frequency of exacerbations or worsening of symptoms from severe chronic obstructive pulmonary disease.
FDA approved the use of once-daily guanfacine (Intuniv, Shire) extended-release tablets as adjunctive therapy to stimulants for the treatment of attention deficit hyperactivity disorder in children and adolescents aged 6 to 17 years as part of a total treatment program.
FDA issued a complete response letter to EMD Serono, an affiliate of Merck KGaA, requesting additional information on cladribine (Movectro), a drug intended for the treatment of relapsing-remitting multiple sclerosis.
A recent recall of generic warfarin tablets was expanded to include 6 other drug products prepared on the same packaging line.
In mid February, US Marshals acting on a request of FDA seized all lots of Auralgan Otic Solution from Integrated Commercialization Solutions in Brooks, Ky.
Agents in late-stage development for the treatment of rare cancers.
Recent FDA action (through, February 2011) related to Contrave, rabeprazole sodium extended-release capsules, Avodart, Mu Delta, Carfilzomib, Vascugel, INX-0818, vosaroxin, Acurox, fidaxomicin, melanoma cancer vaccine, NSI-566RSC, Regorafenib.
New formulation: Fentanyl sublingual tablets were approved by FDA to manage breakthrough pain in patients aged ?18 years who are already receiving and tolerant to opioids for their underlying persistent cancer pain.
Generic drugs approved by FDA (through February 2011): Galantamine hydrobromide
The active drug safety surveillance system being established by FDA promises to do more than obtain timely adverse event information on marketed medicines.
New molecular entity: Vilazodone hydrochloride tablets were approved by FDA on January 21, 2011, for the treatment of major depressive disorder in adults.
Recent FDA Approvals (through February 2011) related to Edarbi, Gralise, Rituxan, Menveo, Makena, Corifact, Epicyn HydroGel
In recent years there has been an explosion of new investigations into the pathophysiology of bipolar disorder and its medication therapies. This article will review current, emerging, and controversial therapies for the treatment of bipolar disorder, specifically the mania aspect.
Ceftaroline has demonstrated activity against methicillin-resistant Staphylococcus aureus and multidrug-resistant Streptococcus pneumoniae as well as common respiratory Gram-negatives including Haemophilus, Moraxella, and Klebsiella species.
With the vote to repeal the Patient Protection and Affordable Care Act behind them, many Congressional leaders are focusing instead on ways to repair or eliminate some of the more contentious reform provisions.
Care for the roughly 9 million dual eligibles in this country tends to be fragmented with Medicare and Medicaid engaging in cost shifting, resulting in a lack of accountability.
FDA has approved the first drug to help prevent premature birth before 37 weeks of pregnancy in women who have had at least one previous preterm delivery.
The federal agencies charged with issuing regulations interpreting the law already have started their work.
For the next several years, "consolidation" will be the watchword for the healthcare industry as plans and providers position themselves for the changing market.
Effecting change requires that standards of care are not only implemented, but measured and managed from patient and provider perspectives.
Fewer than a third of Americans consume the recommended five servings of fruits and vegetables per day.