Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).
The FDA has approved Probuphine, the first buphrenorphine implant for the maintenance treatment of opioid dependence.
A collection of some of the most prominent medical groups have written a letter calling for Congress to pass legislation to provide the highest possible funding level for research, prevention, control and treatment of the Zika virus.
Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn's Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.
Novo Nordisk announced that the Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted in favor (16-0) for the safety and efficacy of IDegLira in treating of adults with type 2 diabetes.
Researchers have identified immune genes that may affect mortality in patients with glioblastoma multiforme, according to a study published online in Neurology.
Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).
Two new studies could pave the way to major changes in how severe cases of hemophilia are treated. Both studies were published in the New England Journal of Medicine.
Prolactin receptor (PRLR) signaling plays a role in expansion of maternal β-cells during pregnancy, according to a study published online in Diabetes.
In the most definitive study to date, cigarette smoking during pregnancy was linked to a greater likelihood of schizophrenia in offspring. Those are the findings of a new long-term study which assessed maternal nicotine exposure (via cotinine levels) during pregnancy.
The study compared rates of dermatology visits for patients affiliated with primary care practices that referred patients to teledermatology and those that did not.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven's investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis or Valley Fever, a common lung infection in the southwestern US.
Although overall colorectal cancer (CRC) rates are declining, the rates among Americans under 50 have increased in the past decade, according to a study presented at the annual Digestive Disease Week, held in San Diego.
Average leucocyte telomere length (LTL) and the abundance of short telomeres (percent LTL <3 kb) are not significant independent determinants of subclinical atherosclerosis, according to a study published in the Journal of the American College of Cardiology.
A predictive model for chemotherapy toxicity has been validated for older patients with solid tumors, according to a study published online in the Journal of Clinical Oncology.
The labeling for several epinephrine injection products has been updated to include information regarding injection-related injury and serious infections at the injection site.
A new ingestible and inflatable balloon system, Obalon, shows promise as a noninvasive way to curb appetite and assist weight loss efforts, according to research presented at the annual Digestive Disease Week, held in San Diego.
Men who experience the loss of chromosome Y (LOY) from their blood cells as they age may have an increased risk of developing Alzheimer's disease, according to a study published online in the American Journal of Human Genetics.
For patients with severe restless legs syndrome (RLS), gabapentin enacarbil (GEn) was shown to significantly improve RLS symptoms and the consequences of these symptoms.
A consensus statement endorsed by numerous international organizations is calling for metabolic surgery to be recognized as a treatment option for certain patients with diabetes, including those who are mildly obese and fail to respond to conventional treatment.
Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.
The Food and Drug Administration (FDA) has approved Flucelvax Quadrivalent, the first four-strain (two influenza A strains + two influenza B strains), cell-culture-derived, inactivated seasonal influenza vaccine for patients 4 years of age and older. Cell-culture technology utilizes a well-characterized mammalian cell line rather than chicken eggs to grow virus strains.
A long-term study of two major urban centers in Quebec, Canada, found that almost half of all antidepressant prescriptions were written for non-depressive indications.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.
Many young female cancer survivors say they don't receive enough information about preserving their fertility, according to a study published online in Cancer.
The American College of Cardiology (ACC), the American Heart Association (AHA), and the Heart Failure Society of America updated their heart failure guidelines to include an angiotensin receptor-neprilysin inhibitor (ARNI) (sacubitril/valsartan [Entresto]), and a sinoatrial node modulator (ivabradine [Corlanor]) to the list of treatment options.
Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.
Compared with insulin, the use of GLP-1 receptor agonist appears to be linked to reduced cardiovascular events and mortality in T2DM patients requiring treatment intensification after failure with oral dual therapy.
Sunovion announced positive results from an extension study evaluating the long-term safety, tolerability and efficacy of Latuda (lurasidone HCI) as monotherapy or as an adjunct to lithium or valproate in adults with major depressive episodes associated with bipolar I disorder. Study findings were published in the journal Depression and Anxiety.
Consuming ≥4 servings of baked, boiled, mashed potatoes or French fries, a week, compared to <1 serving of these foods a month, was associated with an increased adjusted risk of developing hypertension.
In a sign that the opioid epidemic might be waning, new data show that the number of opioid prescriptions has dropped for the first time in 20 years.
Increased urine metabolomic lipid metabolites are associated with clinical parameters in non-obese asthma patients, according to a study published online May 18 in Allergy.
Individuals with previous nonmelanoma skin cancer (NMSC) are more likely to engage in certain sun protection behaviors than those without previous NMSC, according to a study published online in the Journal of the American Academy of Dermatology.
Restricting dietary salt to below 3,000mg a day appears to increase the risk for cardiovascular disease similar to that of hypertension patients who eat too much salt, according to research published online in The Lancet.
The number of pregnant women in the United States infected with the Zika virus has just tripled because cases are now being counted in a more comprehensive way, federal health officials said Friday.
Among patients with acute stroke treated with stent retrievers, fast reperfusion leads to improved functional outcome, according to a study published in the June issue of Radiology.
The Food and Drug Administration today announced new updates to the nutritional facts label to appear on most packaged foods sold across the U.S.
Morbidly obese patients with cellulitis have the same rates of treatment failure with cephalexin as non-obese patients. Those are the findings of a new retrospective study of patients hospitalized or in inpatient observation from January 2005 through February 2015, at the Mayo Clinic Hospital-Rochester, Minnesota.
Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).
Serious health and safety violations force the closure of thousands of public pools, hot tubs, and water playgrounds every year, according to research published in the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.
As baby boomers age, the number of Americans with visual impairment and blindness is expected to double over the next 3 decades, according to a study published online in JAMA Ophthalmology.
Taking aspirin immediately after a transient ischemic attack (TIA) significantly reduces the risk of a major stroke, according to research published online in The Lancet.
Treatment with sulfonylureas (ATP-sensitive potassium [KATP] channel blockers) may inhibit the neuroprotective effects of KATP channel activation and increase the risk of stroke, according to an experimental study published online in Diabetes.
Acorda Therapeutics announced that it will discontinue development of Plumiaz (diazepam) Nasal Spray, a therapy under investigation for the treatment of seizure clusters in patients with epilepsy.
Survival odds for colorectal cancer may depend on which side of the colon the primary tumor develops, according to a study released Wednesday during a media briefing that previewed some of the research to be presented at the upcoming annual meeting of the American Society of Clinical Oncology.
Theranos, the life sciences company that claimed their blood testing device was revolutionary, have corrected, voided and revised tens of thousands of blood test results issued in 2014 and 2015, according to the Wall Street Journal.
The labeling had been updated back in 2013 to remove certain indications but the drug continues to be prescribed for these conditions.
A new commentary published in the Journal of Pediatrics calls for healthcare providers to play a greater role in educating non-celiac disease patients on the consequences of converting to a gluten-free diet (GFD).
A new study has tied former and current excessive alcohol drinking to a higher prevalence of chronic hepatitis C (HCV) infection. With an estimated 50% of those HCV-infected unaware of their infection, the link to alcohol has led researchers to call for greater testing and public health interventions.
Among women with gestational diabetes mellitus (GDM), impaired insulin sensitivity, but not insulin secretion defects, is associated with a greater risk of adverse outcomes compared with normal glucose tolerance (NGT), according to a study published online May 13 in Diabetes Care.
Celator announced that the FDA has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Pregabalin may help improve symptoms of restless legs syndrome (RLS) and decrease sleep disturbances, according to a recent study in Annals of Pharmacotherapy.
ASGR1 mutation carriers have reduced levels of non-high-density lipoprotein cholesterol (HDL-C) and reduced risk of coronary artery disease.
Few symptoms and signs are observed during acute HIV-1 infection, and these are most common before peak viremia, according to a study published online May 18 in the New England Journal of Medicine.
In more than half of recently studied cases, doctors and family members acting on behalf of critically ill patients disagreed about whether the patient would die or not.
GlaxoSmithKline and Innovia announced new data at the ATS 2016 International Conference regarding the safety and efficacy of Anoro Ellipta (umeclidinium/vilanterol) in patients with moderate chronic obstructive pulmonary disease (COPD) who continued to have symptoms while on tiotropium monotherapy.
Pregabalin, a drug often used for anxiety, pain, and other neurologic disorders, may be linked to a higher risk of major birth defects, researchers reported in a Neurology study.
Genentech announced that the FDA has granted accelerated approval of Tecentriq (atezolizumab) for the treatment patients with locally advanced or metastatic urothelilal carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before or after surgery.
Patients should alert clinicians if they experience any new pain, tenderness, sore, ulcers, or infections in their feet or legs.
The FDA has granted Fast Track designation for the investigational drug, VM202 (VM BioPharma/ViroMed), for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).
According to a study published in Current Aging Science, melatonin may be a useful adjuvant medication to stabilize circadian rhythms and blood pressure in elderly patients.
A recent study published in CNS Drugs concluded that gabapentin enacarbil (GEn) taken once daily significantly improved quality of life in adults with moderate-to-severe primary restless legs syndrome (RLS) across all study time points.
Children with sickle cell disease had improved lung function after treatment with hydroxyurea, according to a study presented at the American Thoracic Society (ATS) 2016 International Conference.
While powerful HIV medications are allowing patients to live longer, these same patients are less likely to get treatment for cancer if it develops, according to a study published online on Cancer.
Prophylactic early high-dose recombinant human erythropoietin (rhEPO) given intravenously to very preterm infants does not improve neurodevelopmental outcomes at 2 years corrected age, according to a study published in the Journal of the American Medical Association.
A treatment involving a narrow spectrum of low-intensity green light may help ease migraine pain, according to a study published online in Brain.
For knee osteoarthritis, similar benefits are seen for Tai Chi and standard physical therapy, according to a study published online May 17 in the Annals of Internal Medicine.
The FDA granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) for the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation Adcetris (brentuximab vedotin; Seattle Genetics).
A study published in the Journal of General Internal Medicine found that standard and high-dose benzodiazepines were prescribed more often to patients at higher risk for benzodiazepine-related adverse events.
U.S. physicians were more likely to use hospice and intensive or critical care units at end of life compared to non-physicians, a new study in the Journal of the American Geriatrics Society has shown.
Use of bisphosphonates is associated with adverse drug reactions such as atypical femoral fractures (AFs) and osteonecrosis of the jaw (ONJ).
AstraZeneca announced that the FDA has granted Orphan Drug designation to selumetinib for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).
Mission Pharmacal announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for over-the-counter liquid Potassium Iodide Oral Solution for use in the event of a nuclear emergency.
NeuroStar TMS Therapy, a non-pharmacologic treatment, demonstrated positive results for women with postpartum depression.
AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.
Pediatric patients could possibly be misdiagnosed with ADHD when in fact they have rare tumors, as many of the symptoms of pheochromocytomas and paragangliomas (PHEO/PGL) overlap with symptoms of ADHD.
Results from a recent study published in The Lancet Psychiatry demonstrates preliminary support for the safety and efficacy of the hallucinogenic compound, psilocybin, for the management of treatment-resistant depression.
Whole-body hyperthermia (WBH) may ease depression symptoms for up to six weeks, according to a study published online in JAMA Psychiatry to coincide with the annual meeting of the Society of Biological Psychiatry, held in Atlanta.
Exercise may significantly reduce risk for many types of cancer, according to a large review published online May 16 in JAMA Internal Medicine.
Patients taking antipsychotic agents may be at an increased risk of myocardial infarction, based on a review of nine observational studies.
Avanir announced that Onzetra Xsail (sumatriptan nasal powder) is now available to treat acute migraines with or without aura in adults.
Once-daily Invokana (canagliflozin; Janssen) was associated with significant improvements in blood glucose control (A1c) in adults with type 2 diabetes even though most patients were already being treated with other antidiabetic agents, including insulin, according to three data analyses.