More Exercise Linked to Lower BP, Glucose Levels

More Exercise Linked to Lower BP, Glucose Levels

In a recent study published in the journal Preventing Chronic Disease, self-reported moderate to vigorous exercise was tied to lower blood pressure and blood glucose levels.

Eravacycline Demonstrates Non-Inferiority in Intra-Abdominal Infection Trial

Tetraphase Pharmaceuticals announced positive results from Phase 3 IGNITE 1 trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.

CVD, Stroke Leading Causes of Death Worldwide

Cardiovascular disease and stroke are the leading causes of death worldwide, according to a report from the American Heart Association/American Stroke Association.

Postherpetic Neuralgia Therapy Efficacious in Phase 3 Study

Pfizer announced top-line results from a Phase 3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (PHN).

Reflex Test for EV-D68 Detection Now Available

LabCorp announced the launch of a reflex test to detect enterovirus D68 (EV-D68).

Benzodiazepine Rx Increase Seen in Elderly Despite Health Risks

Benzodiazepine Rx Increase Seen in Elderly Despite Health Risks

Use of benzodiazepines has shown to increase with age despite the known risks for older patients, according to an analysis of benzodiazepine prescribing in the United States.

Xtoro Suspension Approved for Swimmer's Ear

The Food and Drug Administration (FDA) has approved Xtoro (finafloxacin otic suspension; Alcon) for the treatment of acute otitis externa (also known as swimmer's ear) caused by Pseudomonas aeruginosa and Staphylococcus aureus.

High Blood Sugar in Children May Slow Brain Growth

Chronic high blood sugar in young children may lead to slower brain development, new research by the National Institutes of Health (NIH) has shown.

"Keepsake" Fetal Imaging May Do More Harm Than Good, FDA Warns

"Keepsake" Fetal Imaging May Do More Harm Than Good, FDA Warns

The Food and Drug Administration (FDA) is warning consumers that fetal ultrasound imaging and Doppler fetal ultrasound heartbeat monitors are prescription devices designed to be used by trained healthcare professionals and are not intended for over-the-counter (OTC) sale or use for creating fetal keepsake images and videos.

First Pathogen Reduction System to Prep Plasma for Transfusion Approved

The Food and Drug Administration (FDA) has approved Cerus' Intercept Blood System for plasma, the first pathogen reduction system to use in preparation of plasma in order to reduce the risk of transfusion-transmitted infections (TTI).

No CVD, Insulin Improvements Seen with Low Glycemic Index Diet

No CVD, Insulin Improvements Seen with Low Glycemic Index Diet

In a new study published in the Journal of the American Medical Association, diets with low glycemic index of dietary carbohydrate do not appear to lead to a reduction in cardiovascular disease risk or improvement in insulin sensitivity.

Chlamydia, Gonorrhea Cases Down But Syphilis Rates Up

The Centers for Disease Control and Prevention (CDC) has released its annual fact sheet of the three reported sexually transmitted diseases (STDs): chlamydia, gonorrhea, and syphilis.

FDA Issues Complete Response Letter for Yosprala

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.

Bayer Submits BLA for Investigational Hemophilia A Drug

Bayer Healthcare has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.

Somatuline Depot Gains New Antitumor Indication

The Food and Drug Administration (FDA) has approved Somatuline Depot (lanreotide; Ipsen Biopharmaceuticals) injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults with unresectable, well or moderately differentiated, locally advanced or metastatic disease to improve progression-free survival.

Fewer Teens Abusing Narcotics and Alcohol, but E-Cigarette Rates High

Fewer Teens Abusing Narcotics and Alcohol, but E-Cigarette Rates High

Use of cigarettes, alcohol and prescription pain drugs for non-medical use by teenagers have declined since 2013, although rates of e-cigarette use among this population is concerning.

Novel Pig Model to Study Inherited Arrhythmia Developed

The first large animal model of an inherited arrhythmic syndrome has been developed by researchers at NYU Langone Medical Center.

iGrow Hair System Now Approved for Women

iGrow Hair System Now Approved for Women

Apira Science announced that it has received over-the-counter (OTC) clearance from the Food and Drug Adminstration (FDA) for its iGrow Hair Growth System to promote hair growth in women with Fitzpatrick skin phototypes I to IV and with Ludwig Baldness Scale Classifications of I to II.

Top 10 Most Critical Health Threats of 2014 Reviewed by CDC

The Centers for Disease and Prevention (CDC) reviewed its response to 10 of the most critical public health challenges faced in 2014.

BLA Submitted for Investigational Hemophilia B Therapy

CSL Behring announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein), its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin for patients with hemophilia B.

Signifor LAR Approved for Acromegaly

Novartis announced that the Food and Drug Administration (FDA) has approved Signifor LAR (pasireotide diaspartate long-acting release) injectable suspension for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.

First Neonatal SCID Screening Test Gets FDA Clearance

The Food and Drug Administration (FDA) has granted marketing of the EnLite Neonatal TREC Kit, the first FDA-cleared test to screen for severe combined immunodeficiency (SCID) in newborns.

FDA Clears New Screening Test for CHD Event Risk

The Food and Drug Administration (FDA) has granted clearance for the PLAC Test for Lp-PLA2 Activity, a new test that predicts a patient's risk of future coronary heart disease (CHD) events.

Baxter Recalls Two Lots of Sodium Chloride Injection

Baxter Recalls Two Lots of Sodium Chloride Injection

Baxter announced a voluntary recall of two lots of 0.9% Sodium Chloride Injection due to particulate matter found in the solution. The particulate matter was identified as a fragment of the frangible from the vial adapter.

FDA Expands Syphilis Screening Test Access

The Food and Drug Administration (FDA) has granted the first-ever waiver under specific laboratory regulation for Syphilis Health Check test to be used in expanded healthcare settings.

New Dx Test to Detect AKI Risk Launched

New Dx Test to Detect AKI Risk Launched

Ortho-Clinical Diagnostics announced the launch of NephroCheck Test System to help identify patients at risk of developing moderate or severe acute kidney injury (AKI) within 12 hours of assessment.

Genentech Submits NDA for Combination Melanoma Therapy

Genentech has submitted a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

New Injection Site under FDA Review for Abilify Maintena

The Food and Drug Administration (FDA) has accepted for review Otsuka and Lundbeck's supplemental New Drug Application (sNDA) for a proposed new injection site, the deltoid muscle of the arm for Abilify Maintena (aripiprazole extended-release injectable suspension).

Cyramza Gains Expanded Use for Metastatic NSCLC

Cyramza Gains Expanded Use for Metastatic NSCLC

The Food and Drug Administration (FDA) has expanded the indication of Cyramza (ramucirumab; Eli Lilly) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

Infusion Reactions with Krystexxa: New Phase 3 Results Announced

Crealta announced results from two Phase 3 trials and one open-label extension trial on loss of urate-lowering response to Krystexxa (pegloticase) and risk of infusion reactions cited in the product's Food and Drug Administration (FDA)-approved labeling.

First Quadrivalent Intradermal Flu Vaccine Approved

Sanofi announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Fluzone Intradermal Quadrivalent vaccine for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses.

First Supplemental HTLV-I/II Infection Test Approved

The Food and Drug Administration (FDA) has approved the HTLV Blot 2.4, the first supplemental test for Human T-Cell Lymphotropic Virus-I/II (HTLV-I/II).

CDC: Stronger Laws on E-Cigarette Sales, Exposure to Minors Needed

A new report by the Centers for Disease Control and Prevention (CDC) states that more than 16 million children reside in states that permit the sale of electronic nicotine delivery systems (ENDS), including e-cigarettes, to minors and only three states prohibit public indoor use of ENDS.

New Intranasal Vapor Inhaler for Congestion Relief

New Intranasal Vapor Inhaler for Congestion Relief

Splintek announced the launch of SleepRight Intra-Nasal Vapor Inhaler, a non-medicated breathing aid for the relief of nasal congestion.

Antipsychotic Linked to Rare, Potentially Fatal Skin Reaction

The Food and Drug Administration (FDA) is warning that ziprasidone, an atypical antipsychotic agent, has been linked to a rare but serious skin reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), which can progress to other parts of the body.

Improvement in ADHD Symptoms Observed in Dasotraline Trial

Sunovion announced positive results from the first placebo-controlled clinical trial of dasotraline for the treatment of adults with attention deficit hyperactivity disorder (ADHD).

FDA Approves Gardasil 9 Vaccine

The Food and Drug Administration (FDA) has approved Gardasil 9 (9-valent human papillomavirus types, recombinant; Merck) vaccine for the prevention of cervical, vulvar, vaginal, anal cancers, and for the prevention of genital warts caused by nine types of human papillomavirus (HPV).

Potential Ebola Hemorrhagic Fever Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Recombinant Nematode Anticoagulation Protein c2 (rNAPc2; ARCA biopharma) as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus.

FDA Warns on Dangers of Live Bacteria, Yeast Supplements

The Food and Drug Administration (FDA) has issued a warning regarding the risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised persons following the death of a premature infant administered the dietary supplement ABC Dophilus Powder (Solgar), which is formulated to contain three species of live bacteria.

Dangerous Drug Combos Common Among Opioid Tx Patients

Almost 60% of patients on opioid pain treatments for long-term conditions were prescribed potentially dangerous medication mixtures during the same time period, with women accounting for nearly two-thirds of these patients, according to a new report from Express Scripts.

New No-Touch Forehead Thermometer Launched

New No-Touch Forehead Thermometer Launched

Braun announced the availability of the Braun No touch + forehead thermometer, a novel thermometer that can take a temperature reading in two non-invasive ways.

Once-Daily Pill for Premenstrual Breast Discomfort Available

Once-Daily Pill for Premenstrual Breast Discomfort Available

BioPharmX announced the launch of Violet iodine, a first-of-its-kind pill for relief of premenstrual breast discomfort.

Venetoclax Achieves Complete Response in Acute Myelogenous Leukemia Study

AbbVie announced results from a Phase 2 study of venetoclax (ABT-199/GDC-0199) in patients with acute myelogenous leukemia (AML).

NDA Accepted for Filing for Investigational ZipDose Technology

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the first product using its proprietary ZipDose technology.

Simplexa Flu/RSV Test Cleared for Eight More Strains

Focus Diagnostics announced that its Simplexa Flu A/B & RSV Direct Kit has been cleared by the FDA for eight additional influenza strains.

Baricitinib Demonstrates Efficacy in Rheumatoid Arthritis

Eli Lilly and Company and Incyte Corp. announced results from the Phase 3 RA-BEACON study of baricitinib in patients with active rheumatoid arthritis (RA).

False PT/INR Results May Appear for Some Patients

Alere has issued a voluntary correction to users of the Alere INRatio and INRatio 2 PT/INR Monitor system of certain medical conditions that should not be tested with the system.

Four-Year Survival Data Presented for Adcetris in ALCL

Seattle Genetics and Takeda announced long-term overall survival (OS) data or Adcetris (brentuximab vedotin) from a Phase 2 trial in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

New Data on Qudexy XR for Partial-Onset Seizures

New Data on Qudexy XR for Partial-Onset Seizures

Upsher-Smith announced the results of a year-long, open-label extension study of the safety and efficacy of Qudexy XR (topiramate) extended-release capsules as adjunctive therapy in patients with refractory partial-onset seizures (POS).

Kyprolis Extends Survival in Multiple Myeloma

Kyprolis Extends Survival in Multiple Myeloma

Amgen and Onyx announced results from the Phase 3 ASPIRE trial, which assessed Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone vs. Revlimid (lenalidomide; Celgene) and dexamethasone in patients with relapsed multiple myeloma.

Phase 3 Data for Brivaracetam in Partial-Onset Seizures Announced

UCB announced primary Phase 3 study data for brivaracetam as adjunctive treatment in adult epilepsy patients with partial-onset seizures.

Abilify Maintena Gets New Labeling Update

Abilify Maintena Gets New Labeling Update

Lundbeck and Otsuka announced that the Food and Drug Administration (FDA) has approved the labeling update for Abilify Maintena (aripiprazole) for extended-release injectable suspension.

Naftin Gel, Cream 2% Approved for Pediatric Use

Merz Dermatology announced that Naftin (naftifine HCl) Gel 2% and Naftin (naftifine HCl) Cream 2% have been approved for the treatment of interdigital type tinea pedis in pediatric patients aged 12-17 years.

Xgeva Gains Hypercalcemia of Malignancy Indication

Xgeva Gains Hypercalcemia of Malignancy Indication

Amgen announced that the Food and Drug Administration (FDA) has approved Xgeva (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.

Positive Phase 3 Trial Results Announced for Zubsolv

Orexo announced positive results from the ISTART study on Zubsolv (buprenorphine and naloxone) sublingual tablets.

Report: Most Physicians Have or Plan to Adopt EHRs

Report: Most Physicians Have or Plan to Adopt EHRs

Eight out of 10 physicians have adopted or plan to adopt an electronic health record (EHR), with practice size and financial incentives emerging as significant factors influencing adoption rates.

New Combo Caps Approved for Pain Management

Wraser announced it has received Food and Drug Administration (FDA) approval for Trezix (acetaminophen, caffeine, dihydrocodeine bitartrate) Capsules for the management of moderate to moderately severe pain.

Overall Birth Rate Down, But Twin Deliveries Up

The birth rate declined in the United States for the sixth straight year in 2013, with the general fertility rate at an all-time low.

Gaps in Smoking Discussions Between Clinicians, Patients

Data from the National Health Interview Survey (NHIS) from 2011-2013 identified key demographic and health characteristics related to U.S. cigarette smokers aged 18 and older who had a healthcare professional talk to them about their smoking.

Aptiom sNDA Submitted for Monotherapy Treatment for Partial-Onset Seizures

Sunovion announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.

Smartphone-Connected Thermometer Now Available

Smartphone-Connected Thermometer Now Available

Kinsa Health announced the availability of the Kinsa Smart Thermometer, the first FDA-cleared smartphone-connected thermometer and health tracking app.

Many First-Episode Psychosis Txs Not Following Guidelines

Nearly 40% of people with first-episode psychosis in community-based mental health clinics might benefit from medication treatment changes, according to a recent study funded by the National Institute of Mental Health (NIMH).

Jakafi Gains New Hematologic Indication

Jakafi Gains New Hematologic Indication

Incyte announced that the Food and Drug Administration (FDA) has approved Jakafi (ruxolitinib) for the treatment of polycythemia vera (PV) in patients who have had an inadequate response to or are intolerant of hydroxyurea.

GPR101 Gene Linked to Gigantism in Children

In some patients with gigantism, scientists have discovered a duplication of a short stretch of the X chromosome.

CDC: Flu Vaccine May Not Be as Effective This Season

The Centers for Disease Control and Prevention (CDC) has issued a health advisory regarding a drift of influenza A (H3N2) viruses this season, which may possibly lead to a decrease in flu vaccine effectiveness.

First-in-Class Drug Approved for Rare Leukemia

First-in-Class Drug Approved for Rare Leukemia

The Food and Drug Administration (FDA) has approved Blincyto (blinatumomab; Amgen) for the treatment of patients with relapsed or refractory Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL).

Experimental Drug May Help Spinal Cord Injury

A new drug could allow the long axons of spinal cord nerve cells to regenerate after paralyzing spinal cord injuries, unlike current treatments that may require touching the healing spinal cord.

Tobramycin, Nebulizer Combo Pack Approved for CF

The Food and Drug Administration (FDA) has granted approval for PulmoFlow's Kitabis Pak, a combination package of Tobramycin Inhalation Solution and a PARI LC Plus Nebulizer.

FDA: Pregnancy Categories to be Replaced with More Detailed Information

The Food and Drug Administration (FDA) has issued a final rule to standardize how information is presented in labeling of prescription drugs and biologics regarding the use of medicines during pregnancy and breastfeeding.

Lemtrada Initiated in Select MS Patients for First Time in U.S.

Genzyme announced that select patients in the United States are the first to have initiated treatment for relapsing forms of multiple sclerosis (MS) with Lemtrada (alemtuzumab) injection through the restricted distribution program.

40% of Seniors Report Disability, Census Report Shows

According to a U.S. Census Bureau report, almost 40% of people ages ≥65 had at least one disability, of which two-thirds reported difficulty in walking or climbing.

Quality Indicators for GI Endoscopic Procedures Updated

The joint American Society for Gastrointestinal Endoscopy (ASGE) and the American College of Gastroenterology (ACG) Task Force on Quality in Endoscopy has issued updated quality indicators for all gastrointestinal (GI) endoscopic procedures and for the 4 major procedures: colonscopy, esophagogastroduodenoscopy (EGD, or upper endoscopy), endoscopic retrograde cholangiopancreatography (ERCP), and endoscopic ultransonography (EUS).

Apex Device Now Approved for OTC Use

Apex Device Now Approved for OTC Use

InControl Medical announced it has received clearance from the Food and Drug Administration (FDA) to market their Apex Device over-the-counter (OTC).

Hospital Error Rates, Related Health Costs on the Decline

Hospital-acquired conditions (HACs) experienced a 17% decline from 2010-2013 and a 9% reduction from 2012-2013, according to figures released by the Centers for Medicare & Medicaid Services (CMS) and the U.S. Department of Health and Human Services (HHS).

First Wireless Microchip Device Cleared for Back, Leg Pain

First Wireless Microchip Device Cleared for Back, Leg Pain

Stimwave Technologies announced that the Food and Drug Administration (FDA) has granted clearance to market the Stimwave Freedom Spinal Cord Stimulation (SCS) System, the first wireless, microtechnology neuromodulation device for chronic back and leg pain relief.

Dysport sBLA Under Review for Upper Limb Spasticity

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA; Ipsen) for the treatment of upper limb spasticity in adults.

Investigational Empyema Treatment Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead drug candidate, LTI-01 (Lung Therapeutics) for the treatment of empyema.

Sebelipase Alfa BLA Submitted for LAL Deficiency

Synageva BioPharma announced the completion of a rolling submission of the Biologics License Application (BLA) to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency).

Priftin Gains Latent TB Infection Indication

Priftin Gains Latent TB Infection Indication

Sanofi announced that the FDA has approved Priftin (rifapentine) in combination with isoniazid for the treatment of latent tuberculosis infection in patients aged ≥2 years at high risk of progression to tuberculosis disease.

New Cetaphil Baby Line Launched

New Cetaphil Baby Line Launched

Galderma announced the launch of its Cetaphil Baby line, featuring five new products.

Complete Response Letter Issued for Daclatasvir in Hepatitis C

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for daclatasvir (DCV; Bristol-Myers Squibb), a NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C virus (HCV).

FDA Issues Complete Response Letter for Acute Migraine Treatment

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for AVP-825 (Avanir Pharmaceuticals), its Breath Powered investigational drug-device combination product for the acute treatment of migraine.

Lowest Rate of Cigarette Smoking Among Adults Recorded

The rate of cigarette smoking among adults has decreased from 20.9% in 2005 to 17.8% in 2013, a new report by the Centers for Disease Control and Prevention (CDC) has shown.

Ixaomib Designated Breakthrough Therapy for AL Amyloidosis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ixazomib (Takeda), an investigational oral proteasome inhibitor for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis.

Investigational Hemophilia A Therapy BLA Submitted by Baxter

Investigational Hemophilia A Therapy BLA Submitted by Baxter

Baxter announced that it has submitted a Biologics License Application to the Food and Drug Administration (FDA) for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on Advate [Antihemophilic Factor (Recombinant).

New Software OK'd for Non-Invasive FFR Estimates

The Food and Drug Administration (FDA) has approved marketing of HeartFlow FFR-CT software, a computer modeling program that allows healthcare professionals to non-invasively assess blood flow in the coronary arteries of patients with coronary artery disease.

FDA to Review Eylea for Diabetic Retinopathy

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea (afilbercept; Regeneron) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

Xpert Norovirus Test Approved for Detection, Differentiation

Cepheid announced it has received clearance from the FDA to market Xpert Norovirus, an in vitro diagnostic test for identification and differentiation of Noroviruses genogroup I and II.

New CGM-Enabled Insulin Pump Approved

New CGM-Enabled Insulin Pump Approved

Animas announced that the FDA has approved the Animas Vibe insulin pump and continuous glucose monitoring system for the management of insulin-dependent diabetes in adults ages ≥18.

Brodalumab Meets Primary Endpoint in Plaque Psoriasis Trial

Amgen and AstraZeneca announced results from the Phase 3 AMAGINE-2 study evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis.

70% of HIV Infections Not Under Control, Says CDC

According to a new Vital Signs report by the Centers for Disease Control and Prevention (CDC), only 30% of Americans with HIV had the virus under control in 2011, and about two-thirds of those with the virus not in control had been diagnosed but were no longer in care.

Weight Loss Caps Contain Withdrawn Drug

Weight Loss Caps Contain Withdrawn Drug

The Food and Drug Administration (FDA) is warning consumers to not buy or use Slim-Vie, a supplement marketed for weight loss.

Rare Brain Infection May Be Linked to MS Drug

The FDA has issued a warning about one patient with multiple sclerosis (MS) being treated with Tecfidera (dimethyl fumarate; Biogen Idec) who developed progressive multifocal leukoencephalopathy (PML) and later died.

FDA Finalizes Rules on Calorie Info Display

FDA Finalizes Rules on Calorie Info Display

As required by the 2010 Patient Protection and Affordable Care Act, the FDA finalized that calorie information be listed on menus and menu boards in chain restaurants, similar retail food establishments, and vending machines with 20 or more locations.

New Once-Daily Gel Approved for Acne Vulgaris

Valeant announced that the Food and Drug Administration (FDA) has approved Onexton (clindamycin phosphate and benzoyl peroxide) Gel for the once-daily treatment of comedonal and inflammatory acne in patients aged ≥12 years old.

FDA Clears New Flu, RSV Dx Molecular Test

Cepheid announced it has received clearance from the Food and Drug Administration (FDA) to market Xpert Flu/RSV XC, a molecular test for determination for Flu A and B, and differentiation of respiratory syncytial virus (RSV) infection.

FDA Grants QDIP Status to Two Inhalation Products

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to two Bayer Healthcare products, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).

New Clinical Guidelines Issued for Paget's Disease

The Endocrine Society released a Clinical Practice Guideline for the diagnosis and treatment of Paget's disease of the bone.

Smartphone App to Monitor Opioid Addiction Tx: Clinical Trial Begins

Smartphone App to Monitor Opioid Addiction Tx: Clinical Trial Begins

AiCure announced the initiation of a major clinical trial assessing the company's advanced facial recognition and motion-sensing technology to monitor and intervene with patients on maintenance therapy for opioid addiction.

Laparoscopic Power Morcellators Get Safety Labeling Update

The Food and Drug Administration (FDA) is warning against the use of laparoscopic power morcellators in hysterectomy or myomectomy procedures for the majority of women.

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