The Centers for Disease Control and Prevention (CDC) and the Georgia Institute of Technology announced the development of a new microneedle patch that could simplify storage, distribution, administration, and disposal compared to conventional vaccines.
Enanta announced results from AbbVie's ongoing, Phase 3b RUBY-1 study evaluating Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) with or without ribavirin (RBV) in treatment naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.
According to multiple studies presented at the Pediatric Academic Societies meeting in San Diego, CA, dietary supplements promoted and sold for weight loss and bodybuilding are often recommended to adolescents under the age of 18 despite labels stating that they are "for adult use only."
Interim data from the HCV-TARGET study showed that all-oral, direct-acting antiviral (DAA) therapy for hepatitis C (HCV) was highly effective and well tolerated in patients with decompensated cirrhosis.
The Food and Drug Administration (FDA) has approved labeling updates for Valcyte (valganciclovir; Roche) tablets and oral solution to include expanded pediatric indication and dosage sections.
The U.S. Food and Drug Administration (FDA) has issued a letter to bottled water manufacturers recommending that they limit the amount of fluoride added to bottled water so that it contains no more than 0.7mg/L.
The nicotine replacement therapy, Nicorette mini Lozenge (GlaxoSmithKline Consumer Healthcare) has been made available again following a supply shortage caused by a recall last year.
Aidance Scientific announced the launch of Terrasil Shingles Skincare Ointment, a new over-the-counter treatment to soothe highly sensitive skin in patients of all ages.
Astellas announced the launch of Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis and invasive mucormycosis in adult patients.
Consuming higher amounts of sodium had no effect on blood pressure in adolescent girls but consuming more potassium was linked to lower blood pressure at the end of adolescence in new research published in JAMA Pediatrics.
Researchers were able to successfully prevent the development of multiple sclerosis (MS) in mice by using a drug that blocks the production of the regulatory protein sirtuin 1 (SIRT1), a study has shown.
Bristol-Myers Squibb announced results from the ALLY-1 Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) infection with either advanced cirrhosis or post-liver transplant recurrence of HCV.
Gilead Sciences announced results from two studies evaluating the safety and efficacy of sofosbuvir-based regimens in chronic hepatitis C virus (HCV)-infected patients with genotypes 2, 3, 4, and 5.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma), a physiocrine-based product for the treatment of facioscapulohumeral muscular dystrophy (FSHD).
Ledipasvir in combination with sofosbuvir achieved sustained virologic response rates 12 weeks after treatment (SVR12) in 93% and 95% patients with chronic hepatitis C virus (HCV) genotypes 4 or 5 infections, respectively, a study has shown.
The Food and Drug Administration (FDA) has expanded the indication of Cyramza (ramucirumab; Eli Lilly) for use in combination with irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.
Mylan announced a voluntary recall of multiple injectable products due to the potential presence of visible foreign particulate matter.
Canine influenza (or dog flu) is a contagious respiratory disease in dogs caused by specific Type A influenza viruses known to infect dogs, but to date there is no evidence of transmission to humans.
Nipro Diagnostics announced that the Food and Drug Administration (FDA) has granted clearance for its True Metrix Air Self-Monitoring blood glucose system.
Researchers from Duke University have found a single metric to help design a medication regimen that could reintroduce first-line antibiotics in fighting drug-resistant pathogens.
A new study from the Technical University of Madrid and La Paz University Hospital suggests that the type of exercise may be less important than previously suggested when it comes to losing weight.
The APOE ε2 allele, when compared with the ε3 and ε4 alleles, is associated with milder Alzheimer's disease pathology postmortem and less severe antemortem cognitive impairment.
Many primary care providers are uncertain of how to best manage patients with migraine, despite being aware of the prevalence of the condition in the patients they treat, according to a study presented at the American Academy of Neurology (AAN) 2015 meeting.
Three-month administration of 15mg and 30mg doses of suvorexant, an orexin-receptor antagonist, was effective and well tolerated in a cohort of elderly patients with insomnia, according to study results presented at the 2015 American Academy of Neurology Annual Meeting.
Multiple sclerosis patients who consumed larger amounts of alcohol had lower rates of disability per the Expanded Disability Status Score (EDSS) and Multiple Sclerosis Severity Score (MSSS), study findings indicate.
The Food and Drug Administration (FDA) has issued warning letters to five manufacturers of dietary supplements due to the listing of R-beta-methylphenethylamine (also known as Beta-methylphenethylamine, βMePEA, or BMPEA) on the product label.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).
Celgene announced that its results from its international Phase 3 study have fulfilled the requirements for accelerated approval for Pomalyst (pomalidomide), with the FDA approving a labeling update to confirm the survival benefits of Pomalyst.
A final analysis by the Food and Drug Administration (FDA) has found no association between venous thromboembolism (VTE) and Gardasil (quadrivalent human papillomavirus types, recombinant; Merck) vaccination.
The Food and Drug Administration (FDA) has accepted AbbVie's NDA and granted priority review to its all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/R) with ribavirin (RBV) for the treatment of adults with GT4 hepatitis C virus (HCV) infection.
Actavis announced results for its Phase 3 DUR001-303 study of single dose Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).
For patients with non-alcoholic steatohepatitis (NASH), use of an extract of the milk thistle plant was associated with greater NASH resolution and improvement in fibrosis compared to placebo in a study presented at the 50th International Liver Congress in Vienna, Austria.
The Food and Drug Administration (FDA) has issued a Class 1 recall for the Ebola Virus One-Step Test Kits (LuSys Laboratories). This test kit has not been cleared or approved by the FDA for in vitro diagnostic detection of Ebola Virus infection.
The Food and Drug Administration (FDA) announced that Norpace CR (disopyramide phosphate; Pfizer) controlled-release 100mg is currently in shortage.
A medication indicated to treat type 2 diabetes could be a future therapeutic option for non-alcoholic steatohepatitis (NASH) after a study presented at the 50th International Liver Congress in Vienna, Austria met its primary endpoint of histological clearance of NASH, and a reduction in the progression of fibrosis.
Medicure announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Aggrastat (tirofiban HCl) injection to expand the product's dosing time.
A study presented at the 50th International Liver Congress in Vienna, Austria reports that long-term use of entecavir (ETV) or tenofovir (TDF) resulted in excellent five-year survival for patients with chronic hepatitis B virus (CHB) infection.
The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.
A muscle relaxant could be beneficial to patients with alcohol-induced liver disease (ALD) in reducing alcohol consumption and overall measures of liver function and harm, according to a study presented at the 50th International Liver Congress in Vienna, Austria.
Genzyme announced new magnetic resonance imaging (MRI) data from the Phase 3 Lemtrada (alemtuzumab) clinical trial program, which will be presented at the AAN's 67th Annual Meeting in Washington D.C.
Teva announced new data on the safety and efficacy of Copaxone (glatiramer acetate injection) 40mg/mL in patients with relapsing forms of multiple sclerosis (MS).
Avycaz (ceftazidime-avibactam; Actavis) has been made available for the treatment of adult patients with complicated intra-abdominal infections (in combination with metronidazole) and complicated urinary tract infections including pyelonephritis caused by designated susceptible bacteria, including certain Enterobacteriaceae and Pseudomonas auriginosa.
Research in the Journal of Molecular Neuroscience indicates that an insulin-like hormone could increase the lithium sensitivity of blood cells in bipolar disorder patients who previously did not respond to lithium therapy.
The Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Triglide (fenofibrate; Shionogi, Inc.) to include additional Patient Counseling Information in the package insert.
The Food and Drug Administration (FDA) announced that Bystolic (nebivolol; Forest Laboratories) 20mg is currently in shortage.
RB (formerly Reckitt Benckiser) announced a voluntary recall of certain lots of liquid bottles of over-the-counter (OTC) Mucinex Fast-Max due to mislabeling of drug facts.
Novo Nordisk announced the launch of Saxenda (liraglutide [rDNA origin]) injection as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of ≥30kg/m2 (obese) or ≥27kg/m2 (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to SRX-1177 (SolaranRx) for the treatment of stage IIB to IV malignant melanoma.
The Food and Drug Administration (FDA) is warning consumers to not buy or use Extreme Diamond 3000, a product promoted and sold for sexual enhancement.
The Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Xalkori (crizotinib; Pfizer) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).
About 40 percent of patients with multiple sclerosis (MS) experienced relapses or disease progression after discontinuing disease-modifying treatment, in an international, multi-site study presented at the 67th American Academy of Neurology's (AAN) Annual Meeting in Washington, D.C.
In utero exposure to hyperemesis gravidarum (HG) is linked to a three-fold increase in risk of a neurodevelopmental diagnosis such as attention deficit hyperactivity disorder (ADHD), reports the first study to examine this relationship.
The discovery of a genetic variance associated with poor response to inhaled corticosteroid treatment among children with asthma may help guide the development of new therapies for difficult-to-treat asthma cases.
Researchers may have discovered a genetic explanation as to why some patients do not respond to hypertension treatment with thiazide diuretics.
Receipt of the measles-mumps-rubella (MMR) vaccine is not associated with an increased risk of autism spectrum disorders (ASD), even in children already at a higher risk for ASD, according to a new study published in JAMA.
New research published in The Lancet suggests that mindfulness-based cognitive therapy (MBCT) offers a similar protection against depressive relapse or recurrence for patients who have experienced multiple episodes of depression compared to maintenance antidepressant treatment.
In a pilot study described in the latest issue of JAMA, daily treatment with a high-dose oral insulin in children at high risk for type 1 diabetes led to an immune response to insulin without hypoglycemia.
Upsher-Smith announced the results of a study comparing the bioequivalence of Qudexy XR (topiramate) extended-release capsules when opened and sprinkled onto soft food compared to intact capsules.
Biogen announced results from the ATTAIN study which is investigating the long-term safety and efficacy of Plegridy (peginterferon beta-1a) over three years in patients with relapsing-remitting multiple sclerosis (RRMS).
A forum at the American Association for Cancer Research (AACR) Annual Meeting 2015 warns that use of over-the-counter dietary supplements may increase the risk of multiple health conditions and diseases if more than the recommended daily dosage is taken by patients.
The American Academy of Neurology (AAN) and the American Epilepsy Society have released a new guideline for clinicians on treating patients who experience their first seizure, which will be presented at the AAN's 67th Annual Meeting in Washington, D.C.
The American Heart Association (AHA) has issued their first scientific statement on the diagnosis and management of patients over the age of 40 with congenital heart disease (CHD), which is designed to complement the 2008 American College of Cardiology (ACC)/AHA guidelines for adults with congenital heart disease (ACHD).
Research indicates that extending the dose of Tysabri (natalizumab; Biogen) from 4 weeks up to 8 weeks may be well tolerated and effective in patients with multiple sclerosis (MS).
An antifungal and a corticosteroid already approved by the Food and Drug Administration (FDA) have shown promise in activating oligodendrocyte progenitor cells (OPCs) to stimulate myelin-producing cells and repair white matter that is damaged in multiple sclerosis (MS).
Researchers may have discovered a mechanistic explanation and preliminary evidence to support previous findings that mothers of twins are more likely to have smoked, despite smoking's potential deleterious effects on fertility.
The Medicines Company announced that the Food and Drug Administration (FDA) has approved their supplemental new drug application (sNDA) for a new formulation of Minocin (minocycline) for Injection.
The FDA has approved KAMRA inlay (AcuFocus Inc.), an opaque, ring-shaped device for corneal implantation in one eye to improve near vision in certain patients with prebyopia.
The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.
Rates of both prescription opioid overdoses and dispensing of prescription opioid pain relievers dropped substantially after the introduction of abuse-deterrent extended-release oxycodone HCI (OxyContin; Purdue Pharma), according to an article in JAMA Internal Medicine.
The FDA has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression.
Biogen announced that new data continues to support the use of Tecfidera (dimethyl fumarate) as an effective, long-term treatment for relapsing forms of multiple sclerosis.
Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).
The FDA has approved an expansion of the Botox (onabotulinumtoxinA; Actavis) label for the treatment of adults with upper limb spasticity.
The FDA is warning pet owners, veterinarians, healthcare providers, and pharmacists that pets are at risk of illness and death when exposed to topical pain medications containing flurbiprofen.
Study authors have found that the use of droperidol is safe and effective for calming aggressive emergency room (ER) patients.
The FDA is alerting healthcare providers and the public that counterfeit Botox (onabotulinumtoxin A; Allergan) has been found in the United States and may have been distributed to doctors' offices and clinics.
The FDA issued a statement acknowledging the concerns about Genervon's investigational drug, GM604, for the treatment of amyotrophic lateral sclerosis (ALS).
A study published in the American Journal of Preventive Medicine reports that just over half of older adults surveyed in the United States reported taking aspirin daily, despite the fact that routine use for primary prevention of heart attack or stroke is not recommended.
MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003, a highly concentrated pharmaceutical-grade biotin for the treatment of progressive multiple sclerosis.
Bristol Myers Squibb announced results from its Phase 3 CheckMate-057 study of Opdivo (nivolumab) vs. docetaxel in previously treated patients with advanced non-squamous cell lung cancer (NSCLC).
The FDA has granted Orphan Drug designation to Samcyprone (diphenylcylcopropenone, DPCP; RXi Pharmaceuticals) for the treatment of malignant melanoma Stage IIb to IV.
New research suggests that a medication indicated to treat seizures could also reduce the risk of nerve damage and blindness in patients with multiple sclerosis (MS).
Consumption of sugar-sweetened beverages - but not beverages sweetened with aspartame - is associated with suppression of cortisol and stress responses in the brain in new research published in the Journal of Clinical Endocrinology & Metabolism.
Electronic cigarettes (e-cigarettes) may actually hinder, not help, cigarette smokers when it comes to quitting.
Researchers at McGill University have found that concentrated maple syrup may make bacteria more susceptible to antibiotics.
The FDA has approved changes to the Olysio (simeprevir; Janssen) label to include new Warnings and Precautions.
The Food and Drug Administration (FDA) announced the approval of Corlanor (ivabradine; Amgen) to reduce the risk of hospitalization in patients with worsening heart failure.
AstraZeneca announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has voted on the cardiovascular risk profile associated with use of Onglyza (saxagliptin) and Kombiglyze XR (saxagliptin, metformin HCl extended-release) in patients with type 2 diabetes.
Takeda announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has met to review the EXAMINE trial, one of the first cardiovascular outcomes trials (CVOT) in patients with type 2 diabetes.
A new study on children with autism spectrum disorder (ASD) has found there are still long delays between when parents first have developmental concerns and when their child is actually diagnosed with ASD.
The Helsinn Group and Eisai announced that the National Comprehensive Cancer Network (NCCN) has now included Akynzeo (netupitant/palonosetron) in the 2015 NCCN Antiemesis Guidelines as a recommended option for patients receiving both highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).
New research conducted by Biogen and the website PatientsLikeMe indicates that wearable activity tracking devices could be useful to patients with multiple sclerosis (MD) in managing their disease.
Invega Sustenna (paliperidone palmitate; Janssen) was effective six months longer than common oral antipsychotics in patients with schizophrenia, according to results from the PRIDE study.
Results from a small study have shown that the sperm of fathers whose children had early signs of autism show specific "epigenetic tags" that could contribute to the condition.
An experimental drug for multiple sclerosis (MS) may repair damaged myelin, findings from a study have shown.
A strain of bacteria present in many popular probiotic products has been shown to be beneficial for a range of health issues, and now researchers may have discovered the mechanism of action that leads to these positive effects.
Five days of consuming a high-fat diet can lead to changes in the way the body's muscle processes nutrient changes, a new study published in Obesity has found.
As many as 25 percent of patients with atrial fibrillation (AF) at the lowest risk for stroke may be taking oral anticoagulants despite current guidelines, according to a research letter published online in JAMA Internal Medicine.
Researchers have found strong evidence that violent video games do not affect adults with autism spectrum disorder (ASD) differently than typically developing adults.
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