Nanodevice With Dual Therapy May Help Fight Cancer Drug Resistance

Nanodevice With Dual Therapy May Help Fight Cancer Drug Resistance

Scientists at the Massachusetts Institute of Technology (MIT) have developed a new nanodevice to block the gene that confers drug resistance and deliver a sustained release of drugs.

Sleep "Debt" Seen in Adults with Stress, Poor Health

Sleep "Debt" Seen in Adults with Stress, Poor Health

According to the 2015 Sleep in America Poll, stress and poor health are key factors in shorter sleep durations and worse sleep quality.

MDs See Reduced Opioid Rx With State Drug Monitoring Programs

MDs See Reduced Opioid Rx With State Drug Monitoring Programs

In a new survey, nearly 75 percent of physicians believe that state prescription drug monitoring programs have led to a reduction in the prescribing of opioids.

FDA: Testosterone Replacement Tx Review Prompts New Warnings, Updated Labeling

FDA: Testosterone Replacement Tx Review Prompts New Warnings, Updated Labeling

The Food and Drug Administration (FDA) announced that prescription testosterone product labels must be changed to clarify the approved use of these medications and information on the possible increased risk of heart attacks and strokes in patients taking testosterone must also be added.

Can Nano "Drones" Help Prevent Heart Attacks, Strokes?

Can Nano "Drones" Help Prevent Heart Attacks, Strokes?

Biodegradable nano drones that deliver a specific healing molecule to fat deposits in arteries may help in preventing heart attacks due to atherosclerosis.

What Will CKD Prevalence be in 2030? New Prediction for Adults Over 30

What Will CKD Prevalence be in 2030? New Prediction for Adults Over 30

A new report predicts that the prevalence of chronic kidney disease (CKD) in adults aged 30 and over will rise from the current rate of 13.2 percent to 16.7 percent by 2030.

Withdrawn Drug Found in Weight Loss Supplement

Withdrawn Drug Found in Weight Loss Supplement

The Food and Drug Administration (FDA) has issued a warning to not buy or use Elimulating Weight & Toxin Keeping Beauty, a product promoted for weight loss.

Neulasta Delivery Kit Provides New Option for Patients

Neulasta Delivery Kit Provides New Option for Patients

Amgen announced the launch of Neulasta (pegfilgrastim) Delivery Kit that allows the healthcare provider to initiate Neulasta on the same day as chemotherapy along with a full dose of Neulasta the following day.

Even More Tainted Sex Enhancement Pills Discovered in International Shipments

Even More Tainted Sex Enhancement Pills Discovered in International Shipments

The Food and Drug Administration (FDA) is warning consumers to not use or buy SEx Men, Super Hard, Santi Scalper, Vigra, Plant Vigra, Vigour 300, MME MAXMAN, Hard Wang, FX3000 after they were found to contain hidden drug ingredients.

Melanoma Treatment Under Review for Preventing, Delaying Recurrence

The Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy (ipilimumab; Bristol-Myers Squibb) for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection.

Number of Docs, Retail Clinics Affect Antibiotic Prescribing Rate

More antibiotic prescriptions per person are written in wealthy areas of the United States as a result of competition among physicians and retail clinics, a team of researchers has found.

More Evidence Points to the Power of Nuts in Reducing CVD Mortality

More Evidence Points to the Power of Nuts in Reducing CVD Mortality

Nut consumption is associated with reduced total mortality risk and death due to cardiovascular disease, particularly ischemic heart disease, across different ethnic groups and people of low SES

Overactive Bladder Drug May be Beneficial in MS

Researchers from the University of Buffalo have found a way to improve remyelination for myelin-based diseases like multiple sclerosis (MS).

FDA to Review Investigational Parkinson's Disease Drug Xadago

The FDA has accepted for filing the New Drug Application (NDA) for Xadago (safinamide; Newron and Zambon) as add-on therapy in both early and mid-to-late stage Parkinson's disease (PD) patients who are inadequately managed on their current treatment.

How Prevalent is Antipsychotic Prescribing in Seniors with Dementia?

How Prevalent is Antipsychotic Prescribing in Seniors with Dementia?

An analysis by the United States Government Accountability Office (GAO) has found that about 1/3 of older adults with dementia who resided >100 days in a nursing home in 2012 were prescribed an antipsychotic.

Some Frequently Ordered Tests May Not Be Necessary to Diagnose CKD

Some Frequently Ordered Tests May Not Be Necessary to Diagnose CKD

Many of the tests performed to screen for chronic kidney disease (CKD) may offer little clinical benefit on diagnosis and management, according to a research letter.

Ipsen Continues to Resupply Increlex

Ipsen, in collaboration with the FDA is releasing a third batch of Increlex (mecasermin [rDNA origin]), since the initial resumption of product supply in May 2014.

FDA Uncovers Six Tainted Sex Enhancement Pills

FDA Uncovers Six Tainted Sex Enhancement Pills

The Food and Drug Administration (FDA) has warned against the use of Libigrow XXX Treme, Night Man, Black King Kong, 72HP, Tibet Babao, and Germany Niubian supplements promoted for sexual enhancement.

FDA Issues Warning on Four Tainted Weight Loss Supplements

FDA Issues Warning on Four Tainted Weight Loss Supplements

The FDA has warned consumers to not buy or use the weight loss supplements Oxy ELITE Pro Super Thermogenic, Nine Slim, Seven Slim, and Botanical Slimming (Red) after they were found to contain undeclared drug ingredients.

FDA Wants More Info Before Approving Exparel for Post-Op Nerve Block

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia.

First-In-Class Enzyme Replacement Therapy for Hypophosphatasia Under Review

The FDA has accepted for Priority Review the Biologics License Application (BLA) for asfotase alfa in the treatment of patients with infantile-and juvenile-onset hypophosphatasia (HPP).

FDA to Review Lifitegrast for Dry Eye Disease

Shire has submitted a New Drug Application (NDA) to the FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

BI Requesting Accelerated Approval for Pradaxa Reversal Agent

Boehringer Ingelheim announced that it has submitted a Biologics License Application (BLA) to the FDA, requesting accelerated approval for the use of idarucizumab to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

Not Enough COPD Patients Receiving Maintenance Tx, Research Suggests

Not Enough COPD Patients Receiving Maintenance Tx, Research Suggests

A new study suggests that many patients with COPD may be undertreated (particularly with long-acting maintenance medications), despite recommended treatment guidelines.

Harvoni for HCV Genotype 4, HIV Co-Infection Assessed in New Research

Gilead Sciences announced results from ION-4, a Phase 3 study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

Combo Therapy for HCV, HIV Co-Infection: New Data on Sustained Virologic Response

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase 3 trial evaluating the use of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) co-infected with HIV.

What's Changed in Immunization Recommendations From CDC Advisory Committee

What's Changed in Immunization Recommendations From CDC Advisory Committee

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) has issued new recommendations on immunizations, including influenza, serogroup B meningococcal, and human papillomavirus (HPV) vaccination.

IUD Approval Gives Women New Long-Acting Birth Control Option

IUD Approval Gives Women New Long-Acting Birth Control Option

The Food and Drug Administration (FDA) has approved Liletta (levonorgestrol-releasing intrauterine system; Actavis and Medicines360) for use by women to prevent pregnancy for up to three years.

This Ebola Test Can Diagnose in 15 Minutes With Single Drop of Blood

This Ebola Test Can Diagnose in 15 Minutes With Single Drop of Blood

Corgenix Medical Corporation announced that it has received emergency use authorization (EUA) from the Food and Drug Administration (FDA) for its ReEBOV Antigen Rapid Test for use in patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, including geographic locations with high prevalence of Ebola infection.

Once-Daily Insulin in Prefilled Pen Gets FDA Nod

Once-Daily Insulin in Prefilled Pen Gets FDA Nod

Sanofi announced that the Food and Drug Administration (FDA) has approved once-daily Toujeo (insulin glargine [rDNA origin]) injection 300 U/mL to improve glycemic control in adults with type 1 and type 2 diabetes.

Diabetes Pen Devices to Display Additional Warning Labels

The Food and Drug Administration (FDA) announced that multi-dose diabetes pen devices intended for single patient use only are now required to add additional label warnings prohibiting the sharing of these injectable medicines.

Molecule Discovery Could Lead to New Parkinson's Drug

Molecule Discovery Could Lead to New Parkinson's Drug

Research published in The Journal of Biological Chemistry suggests that a newly designed molecule, if developed into a drug, could slow the progression of Parkinson's disease.

New Combo Tx Approved for Drug-Resistant Bacteria

The Food and Drug Administration (FDA) has approved Avycaz (ceftazidime/avibactam; Actavis) for the treatment of adults with complicated intra-abdominal infections (cIAI) in combination with metronidazole and for patients with complicated urinary tract infections (cUTI) including pyelonephritis.

HIV Drug May Block S. Pyogenes Toxin Production

HIV Drug May Block S. Pyogenes Toxin Production

Researchers have created nelfinavir-like compounds that stopped Streptococcus pyogenes bacteria from producing the streptolysin S (SLS) toxin, an important virulence factor during infection.

Prescription Opioid Use Stable, But Patients Using Stronger Painkillers

Prescription Opioid Use Stable, But Patients Using Stronger Painkillers

The percentage of adults aged 20 years and older that used a prescription opioid analgesic in the past 30 days remained stable through 2011-2012, although use has doubled compared to 1988-1994, according to a new survey from the National Center for Health Statistics and the Centers for Disease Control and Prevention (CDC).

Skin Biopsy May Help Detect Alzheimer's, Parkinson's Earlier

Skin Biopsy May Help Detect Alzheimer's, Parkinson's Earlier

A skin test may help diagnose Alzheimer's and Parkinson's diseases by detecting potential biomarkers, new research has shown.

Five Things ID Experts Want You to Know Before You Prescribe an Antibiotic

Five Things ID Experts Want You to Know Before You Prescribe an Antibiotic

The Infectious Diseases Society of America (IDSA) has issued a list of five tests or treatments that physicians and patients should question.

Recall of Two IV Antibiotics Announced

Recall of Two IV Antibiotics Announced

Heritage Pharmaceuticals announced a voluntary nationwide recall of 10 lots of Colistimethate for Injection 150mg, and three lots of Rifampin for Injection 600mg.

Recalled OTC Weight Loss Pills Return to Market

Recalled OTC Weight Loss Pills Return to Market

GlaxoSmithKline announced that alli (orlistat) capsules have returned to most stores in the United States and Puerto Rico following the voluntary recall in March 2014.

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.

Study: 3-Day PrEP Effective in Reducing HIV Risk in MSM

A pre-exposure prophylaxis (PrEP) regimen of tenofovir/emtricitabine taken before and after sex reduced the risk of HIV among men who have sex with men (MSM) by an average of 86 percent, according to results presented by a French national HIV research agency.

Obese Women Advised Not to Gain Weight Until Mid-Pregnancy, Says Study

Obese Women Advised Not to Gain Weight Until Mid-Pregnancy, Says Study

Pregnant women with various classes of obesity should not gain any weight until mid-pregnancy or later for optimal pregnancy outcomes, according to a new study in the journal Obesity.

Gene Variant May Up Peripheral Neuropathy Risk with Chemo Drug

Gene Variant May Up Peripheral Neuropathy Risk with Chemo Drug

The first genetic variation linked to increased risk and severity of peripheral neuropathy following treatment with a common chemotherapy drug has been identified, according to scientists at St. Jude Children's Research Hospital.

Food Choices May Affect Childhood Obesity More Than Mom's Diet

Food Choices May Affect Childhood Obesity More Than Mom's Diet

Nurture, not nature, may play a greater role in childhood obesity as researchers have found that environment may be an equal (if not stronger) force in determining obesity compared to the mother's diet.

FTC Cracks Down on Melanoma Detection Apps

FTC Cracks Down on Melanoma Detection Apps

The Federal Trade Commission (FTC) has announced that the agency is actively challenging several marketers of mobile apps promoted to detect symptoms of melanoma (even in its early stages) due to deceptive claims.

Aspirin Resistance May Mean More Severe, Larger Strokes

Aspirin Resistance May Mean More Severe, Larger Strokes

A new study shows that people who have aspirin resistance may be more likely to have more severe and larger strokes than those who are still responsive to aspirin.

Infant Peanut Consumption Could Lower Risk of Allergy Development

Infant Peanut Consumption Could Lower Risk of Allergy Development

Introducing peanut products into the diets of infants at high risk of developing peanut allergy was safe and led to an 81% reduction in the subsequent allergy development, reports a new study.

IV Anesthesia Vials Recalled Due to Sterility Issues

Sagent announced its voluntary nationwide recall of two lots of Atracurium Besylate Injection 50mg/5mL single-dose vials and four lots of Atracurium Besylate Injection 100mg/10mL multi-dose vials.

FDA Expands HIV Antibody Test to Detect HIV-2

FDA Expands HIV Antibody Test to Detect HIV-2

bioLytical Laboratories announced that the Food and Drug Administration (FDA) has approved its INSTI HIV Antibody Test for the detection of antibodies to HIV type 2 (HIV-2).

New Booster Enzyme May Increase Alcohol Metabolism

An investigational compound may help metabolize acetaldehyde for people with impaired ability to detoxify, a study supported by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) has shown.

First-in-Class Drug Approved for Multiple Myeloma

First-in-Class Drug Approved for Multiple Myeloma

The Food and Drug Administration (FDA) has approved Farydak (panobinostat; Novartis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulator.

Dymista Granted Expanded Age Range

Dymista Granted Expanded Age Range

Meda announced that the Food and Drug Administration (FDA) has approved Dymista (azelastine HCl and fluticasone propionate) for the relief of symptoms of seasonal allergic rhinitis (SAR) in patients ages 6-11 who require treatment with both components.

Over 90% of New HIV Infections Could Be Prevented With Tx, Care

Over 90% of New HIV Infections Could Be Prevented With Tx, Care

Over 90 percent of new HIV infections in the United States could be prevented by diagnosing those living with HIV and providing prompt, ongoing care and treatment that includes the use of antiretroviral therapy (ART), according to new research from the Centers for Disease Control and Prevention (CDC) and published in JAMA Internal Medicine.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Breakthrough Therapy for Rare Enzyme Disorder Could Be Approved Even Sooner

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Kanuma (sebelipase alfa; Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency (LAL Deficiency).

Shorter FDA Review for Tx of Rare Lung Disorder

The Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus; Pfizer) for the treatment of lymphangioleiomyomatosis (LAM).

New Oral Combo for Metastatic Colorectal Cancer To Get FDA Review

The Food and Drug Administration (FDA) has accepted Taiho's New Drug Application (NDA) for review for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).

Peanut Allergy Patch Shows Promise in Latest Study

Peanut Allergy Patch Shows Promise in Latest Study

Data from a Phase 2b trial showed that patients with peanut allergy using Viaskin Peanut (DBV Technologies) showed significant improvement using this epicutaneous immunotherapy (EPIT) after one year.

FDA to Review Belbuca for Pain Management

The Food and Drug Administration (FDA) has accepted the NDA for review for Belbuca (buprenorphine HCl; Endo and BioDelivery Sciences) buccal film for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

CDC: New Info on Novel "Bourbon Virus"

CDC: New Info on Novel "Bourbon Virus"

The Centers for Disease Control and Prevention (CDC) has reported the discovery of a new virus that may have contributed to the death of a resident in eastern Kansas in late spring of 2014.

First Permanent Varicose Veins Tx With Adhesive Approved

The Food and Drug Administration (FDA) has approved Covidien's VenaSeal system for permanent treatment of varicose veins of the legs by sealing the affected superficial veins with an adhesive.

Women with MS May Be Lacking in Key Nutrients

Women with MS May Be Lacking in Key Nutrients

Compared to healthy individuals, women with multiple sclerosis (MS) may have lower levels of key antioxidant and anti-inflammatory nutrients such as folate and vitamin E.

DPP-4 Inhibitors May Be Effective Against Hypoglycemia

Dipeptidyl peptidase-4 (DPP-4) inhibitors, commonly used to treat high blood glucose levels, have also shown efficacy against low blood sugar levels in a recent study.

Can Statins Lower Risk of Parkinson's Disease?

Can Statins Lower Risk of Parkinson's Disease?

A new study suggests that the use of statins may not lower the risk for Parkinson's disease.

Genetics May Explain Higher Birth Defects Risk in Older Mothers

Genetics May Explain Higher Birth Defects Risk in Older Mothers

Researchers at Albert Einstein College of Medicine of Yeshiva University have discovered a potential explanation as to why older mothers face a greater risk for having offspring born with conditions characterized by abnormal chromosome numbers, such as Down syndrome.

23andMe Gets FDA OK for Bloom Syndrome Carrier Test

23andMe Gets FDA OK for Bloom Syndrome Carrier Test

The Food and Drug Administration (FDA) has approved for marketing 23andMe's Bloom Syndrome carrier test to determine whether a healthy person expresses a gene variant that could lead to their child inheriting the disorder.

What a Gov't Advisory Committee Has to Say About Dietary Fat, Cholesterol

What a Gov't Advisory Committee Has to Say About Dietary Fat, Cholesterol

The U.S. Department of Health and Human Services (HHS) has announced that the 2015 Dietary Guidelines Advisory Committee (DGAC) has submitted recommendations to HHS Secretary Sylvia M. Burwell and Agriculture Secretary Tom Vilsack for the 2015 edition of the Dietary Guidelines for Americans.

Potential Target to Eliminate Opioid Tolerance ID'ed

Researchers believe it may be possible to reduce the development of opioid tolerance if the compound CXCL1 is neutralized or blocked in patients taking opioids for chronic management of severe pain.

Cancer Risk With Eczema Drug Tracked in Long-Term Study

Treatment with pimecrolimus for eczema was found unlikely to increase the risk of cancer in children, according to a post-marketing study.

FDA Issues Safety Warning on Endoscopes as News of Superbug Threat Hits UCLA Hospital

FDA Issues Safety Warning on Endoscopes as News of Superbug Threat Hits UCLA Hospital

The Food and Drug Administration (FDA) has issued recommendations for healthcare professionals regarding endoscopic retrograde cholangiopancreatography (ERCP) endoscopes (duodenoscopes) in response to adverse event reports of multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly.

Ophthalmic Txs for DME Compared in NIH-Funded Study

Treatment with Eylea (aflibercept; Regeneron) led to greater average visual improvement than Avastin (bevacizumab; Genentech) or Lucentis (ranibizumab; Genentech) when vision was 20/50 or worse at treatment initiation, but similar improvement when the starting vision was 20/40-20/32, data from a clinical trial has shown.

FDA to Review Combination Therapy for Advanced Melanoma

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

New Drug Interaction Update for Isentress

New Drug Interaction Update for Isentress

The Food and Drug Administration (FDA) has approved a label change for Isentress (raltegravir; Merck) to include updated information about concomitant raltegravir and aluminium and/or magnesium-containing antacids.

Novel HIV Drug Candidate Could Potentially Block Every Strain

Novel HIV Drug Candidate Could Potentially Block Every Strain

Scientists at The Scripps Research Institute and other institutions have announced results from a new study on a novel drug candidate that has blocked every strain of HIV-1, HIV-2, and simian immunodeficiency virus (SIV) that has been isolated from humans or rhesus macaques.

Stillbirth Delivery May Increase Long-Term Depression Risk

Stillbirth Delivery May Increase Long-Term Depression Risk

Women with no history of depression who deliver a stillbirth may have an increased risk for long-lasting depression, according to research.

Can Plain Cigarette Packaging Reduce Smoking?

Can Plain Cigarette Packaging Reduce Smoking?

Recent findings from a series of studies have shown that tobacco packaging without labels or branding may deter new smokers and prevent habitual smokers from regular use.

Saliva Test for Autism Spectrum Disorder May Be Close

Researchers have identified differences in protein biomarkers present in saliva that are associated with autism spectrum disorder (ASD), which may lead to a saliva-based test to aid in diagnosis.

ACC/AHA: Hypertension Management Guidelines Update Underway

ACC/AHA: Hypertension Management Guidelines Update Underway

The American College of Cardiology (ACC) and the American Heart Association (AHA) have started to work on a new guideline for the management of hypertension.

InspiraChamber VHC Launched to Improve Aerosol Delivery

InspiraChamber VHC Launched to Improve Aerosol Delivery

Lupin announced the launch of the InspiraChamber Anti-Static Valved Holding Chamber (VHC) to enhance delivery of aerosol therapy in the treatment of asthma.

Adcetris sBLA Submitted for Post-Transplant Hodgkin Lymphoma

Seattle Genetics has submitted a supplemental Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.

Revlimid Gets Expanded Multiple Myeloma Indication

Celgene announced that the Food and Drug Administration (FDA) has expanded the use of Revlimid (lenalidomide) to include patients newly diagnosed with multiple myeloma, in combination with dexamethasone.

Entrectinib Designated Orphan Drug for Colorectal Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Hypoactive Sexual Desire Disorder Drug for Women Gets Closer to Approval

Sprout Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for flibanserin for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

New Zubsolv Dosage Strength Coming Soon

New Zubsolv Dosage Strength Coming Soon

Orexo announced its plans to launch Zubsolv (buprenorphine and naloxone) sublingual tablets in a new 8.6mg/2.1mg strength.

Orphan Drug Designation Granted to Glioblastoma Multiforme Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Saposin C, the active ingredient in BXQ-350 (Bexion) for the potential treatment of glioblastoma multiforme.

New Rosacea Tx Option Now Available

New Rosacea Tx Option Now Available

Galderma announced the availability of Soolantra (ivermectin) Cream for the the treatment of rosacea.

ALO-02 NDA Under Review for Pain Management

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone HCl and naltrexone HCl; Pfizer) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long term opioid treatment and for which alternative treatment options are inadequate.

Investigational Heart Failure Therapy Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for LCZ696 (Novartis) for the treatment of heart failure with reduced ejection fraction (HFrEF).

FDA Fast Tracks Intranasal Naloxone

Lightlake Therapeutics and Adapt Pharma Limited announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal naloxone, an opioid antagonist for opioid overdose reversal treatment.

FDA Expands Banzel Age Range for Adjunct Tx in Seizures

FDA Expands Banzel Age Range for Adjunct Tx in Seizures

Eisai announced that the Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Banzel (rufinamide) as adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients aged 1-4 years old.

Lenvima Approved for RAI-Refractory Differentiated Thyroid Cancer

Lenvima Approved for RAI-Refractory Differentiated Thyroid Cancer

The Food and Drug Administration (FDA) has approved Lenvima (lenvatinib; Eisai) for the treatment of patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy.

Pazeo Solution Approved for Ocular Itch Relief

The Food and Drug Administration (FDA) has approved Pazeo (olopatadine HCl ophthalmic solution; Alcon) for the treatment of ocular itching associated with allergic conjunctivitis.

FDA Expands Xpert MTB/RIF Test Use

FDA Expands Xpert MTB/RIF Test Use

The Food and Drug Administration (FDA) has granted clearance for the Cepheid Xpert MTB/RIF Assay to help determine if patients with suspected tuberculosis (TB) can be removed from airborne infection isolation with one or two negative test results.

New Fecal Incontinence Device Cleared for Females

The Food and Drug Administration (FDA) has granted marketing of Pelvalon's Eclipse System for the treatment of fecal incontinence in females aged 18-75 years old who have had more than four episodes in a two-week period.

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Oral lenvatinib delayed progression of advanced thyroid cancer by 18 months, compared with four months for patients treated with a placebo, according to results from a new clinical trial.

Smallest Estrogen Patch Now Available for Postmenopausal Osteoporosis

Smallest Estrogen Patch Now Available for Postmenopausal Osteoporosis

Noven announced the launch of Minivelle (estradiol transdermal system) 0.025mg/day, a new low dosage strength approved for the prevention of postmenopausal osteoporosis.

Plant-Based Diet May Help Obese Children Lower CVD Risk Factors

Plant-Based Diet May Help Obese Children Lower CVD Risk Factors

New research published in The Journal of Pediatrics suggests that a plant-based, low-fat vegan diet can significantly reduce risk factors for cardiovascular disease in obese children.

Cerdelga Effective in Gaucher Disease Type 1 Study

Cerdelga Effective in Gaucher Disease Type 1 Study

Genzyme announced results from its extension study of the Phase 3 ENGAGE and ENCORE studies of Cerdelga (eliglustat) for the treatment of certain adults with Gaucher disease type 1.

Mesothelioma Treatment Granted Orphan Drug Designation

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VS-5584 (Verastem) for the treatment of mesothelioma.

ANA-Conjugated Liposomal Doxorubicin Designated Orphan Drug for Ewing's Sarcoma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to its antinuclear antibody (ANA) conjugated liposomal doxorubicin (NanoSmart Pharmaceuticals) intended to treat Ewing's sarcoma, with potential expansion to other indications.

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