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.

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.

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.

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.

New Rosacea Tx Option Now Available

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

Xeljanz sNDA Accepted for Review for Plaque Psoriasis

The Food and Drug Administration (FDA) has accepted for review the sNDA for Xeljanz (tofacitinib citrate; Pfizer) 5mg and 10mg tablets for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

First Tissue Adhesive for Internal Use Approved

The Food and Drug Administration (FDA) has approved Cohera Medical's TissuGlu Surgical Adhesive, the first tissue adhesive for internal use.

First Dermal Filler Approved for Lip Enhancement, Perioral Lines

Galderma announced the launch of Restylane Silk, the first dermal filler approved for lip augmentation and correction of perioral rhytids in patients over 21 years old.

Cosentyx for Plaque Psoriasis Approved

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

Natroba Now Approved for Younger Children with Head Lice

ParaPRO announced that the Food and Drug Administration (FDA) has approved an expanded age range for Natroba (spinosad) Topical Suspension, to include children 6 months of age and older who have pediculosis capitis (head lice).

BioBag Now Available for Biosurgical Wound Debridement

BioMonde announced the launch of BioBag, a biosurgical medical device for wound debridement.

First Dermal Filler for Acne Scar Treatment Approved

Suneva Medical announced that the Food and Drug Administration (FDA) has approved Bellafill for the treatment of acne scars in patients over age 21.

Galderma Launches OTC Acne Regimen

Galderma announced the launch of Benzac Acne Solutions, their first over-the-counter (OTC) acne regimen.

Once-Daily Topical Cream for Rosacea Approved

Galderma announced that the Food and Drug Administration (FDA) has approved Soolantra (ivermectin) Cream for the topical treatment of inflammatory lesions of rosacea.

Opdivo Granted Accelerated FDA Approval for Melanoma

The Food and Drug Administration (FDA) has granted accelerated approval for Opdivo (nivolumab; Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma who are unresponsive to other drugs.

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.

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.

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.

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).

New Cetaphil Baby Line Launched

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

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.

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.

Dupilumab Designated Breakthrough Therapy for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab (Regeneron and Sanofi) for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

Otezla Demonstrates Sustained Response in Active Psoriatic Arthritis

Celgene announced results from two PALACE Phase 3 clinical trials with Otezla (apremilast) for the treatment of adults with active psoriatic arthritis and for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Opdivo Achieves Primary Endpoint in Melanoma Trial

Bristol-Myers Squibb Company announced results from the Phase 3 CheckMate-066 study comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

New Look for RestoraDerm Products for Eczema

Galderma announced new packaging of the Cetaphil RestoraDerm product line to reflect the newly renamed Cetaphil RestoraDerm Eczema Calming Body Wash and Cetaphil RestoraDerm Eczema Calming Moisturizer.

Brodalumab Demonstrates Efficacy in Plaque Psoriasis Study

Amgen and AstraZeneca announced results from AMAGINE-3, a Phase 3 trial evaluating brodalumab in patients with moderate-to-severe plaque psoriasis.

New Once-Daily Women's Rogaine Foam Launched for Hair Loss

Rogaine, a brand of McNeil Consumer, announced the launch of Women's Rogaine 5% Minoxidil Topical Aerosol, the first once-daily treatment for female pattern hair loss.

Novel Psoriasis Drug Recommended by FDA Advisory Group

Novartis announced that the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has unanimously voted in support of the approval of AIN457 (secukinumab) for the treatment of moderate to severe plaque psoriasis.

Stelara: Better Persistency, Lower Discontinuation Rates in Psoriasis Study

New findings from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) indicate significantly better persistency and lower rates of discontinuation therapy with Stelara (ustekinumab; Jannsen Biotech) compared with anti-tumor necrosis factor (TNF)-alpha treatments.

Adalimumab Biosimilar Meets Endpoint in Plaque Psoriasis Study

Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.

Rasuvo Autoinjector Launched for RA, pJIA, Psoriasis

Medac Pharma announced the launch of Rasuvo (methotrexate) injection for patients with rheumatoid arthritis, polyarticular course juvenile idiopathic arthritis (pJIA), and psoriasis.

FDA Expands Humira Use for pJIA in Children Aged 2 Years and Up

AbbVie announced that the Food and Drug Administration (FDA) has approved the use of Humira (adalimumab) for moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA) to reducing signs and symptoms in patients aged ≥2 years.

Absorica Caps Launched in Two New Strengths

Ranbaxy announced the launch of Absorica (isotretinoin) 25mg and 35mg capsules for the treatment of severe recalcitrant nodular acne in patients ≥12 years old.

Scalp Plaque Psoriasis Tx Approved for Pediatric Patients

LEO Pharma announced that Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension has been approved for the treatment of plaque psoriasis of the scalp in patients aged 12-17 years.

Humira Gains Pediatric Crohn's Disease Indication

AbbVie announced that the Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease for patients ≥6 years old.

Otezla Tabs Gain New Psoriasis Indication

Celgene announced that the Food and Drug Administration (FDA) has approved Otezla (apremilast) for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.

Results for Humira in Chronic Skin Disease Trial

AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

First-in-Class Melanoma Drug Gets Accelerated Approval

The Food and Drug Administration (FDA) has granted accelerated approval for Keytruda (pembrolizumab; Merck) for the treatment of advanced or unresectable melanoma in patients who are no longer responsive to other drugs.

Ixekizumab vs. Etanercept for Plaque Psoriasis: Phase 3 Results Announced

Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis, in which ixekizumab was found to be superior to etanercept.

Xiaflex Demonstrates Efficacy in Cellulite Study

Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.

New Flexbumin 5% Strength Approved

Baxter announced that the FDA has approved Flexbumin (albumin [human]) 5% solution for the treatment of hypovolemia, hypoalbuminemia due to general causes, burns, and for use during cardiopulmonary bypass surgery as a component of the pump prime.

New Smaller ChloraPrep Applicator Launched

CareFusion announced the launch of its ChloraPrep 1mL applicator, the latest addition to the ChloraPrep line.

New Oral Doxycycline Formulation Approved

The FDA has approved the New Drug Application (NDA) for Acticlate (doxycycline hyclate) for the treatment of susceptible infections including adjunctive therapy in severe acne.

FDA Approves Rasuvo Injection for RA, JIA, Psoriasis

Medac Pharma announced that the FDA has approved Rasuvo (methotrexate) subcutaneous auto-injector for the management of rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis (pJIA), and severe, recalcitrant, disabling psoriasis.

Secukinumab Demonstrates Potential in Phase 3 Psoriasis Trials

Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis.

EpiCeram Airless Pump Now Available

PuraCap announced the introduction of EpiCeram Airless Pump, the latest addition to the EpiCeram line.

New Dermatoses Ointment Launched

Aqua Pharmaceuticals announced the launch of Cordran Ointment (flurandrenolide) 0.05% for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

FDA Warns of Potentially Serious Reactions to OTC Topical Acne Products

The FDA has issued a warning that certain over-the-counter (OTC) topical acne medications may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

Non-Steroidal Eczema, Psoriasis Spray Launched

Quest Products announced the launch of ProVent Eczema and Psoriasis Spray indicated to help minimize the appearance of skin conditions often associated with eczema and psoriasis.

Superior Overall Survival with Nivolumab in Skin Cancer Trial

Bristol-Myers Squibb's Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.

Restylane Dermal Filler Implant Approved

Valeant announced that the FDA has issued clearance for Restylane Silk Injectable Gel with 0.3% Lidocaine, a submucosal implant for lip augmentation and dermal implantation for correction of perioral rhytids in patients >21 years old.

Rapid-Absorbing Rosacea Cream Now Available

Quest Products announced the launch of ProVent Rosacea Moisturizing Creme indicated to help reduce the appearance of skin often associated with rosacea and other skin conditions.

FDA Says Sunlamps No Longer Low-Risk

The FDA announced a final order reclassifying sunlamp products and ultraviolet (UV) lamps designed for use in sunlamp products from low-risk (Class I) to moderate-risk (Class II) devices.

Tofacitinib Effective in Phase 3 Psoriasis Retreatment Study

Pfizer announced results from the OPT (Oral treatment Psoriasis Trial) Retreatment study (A3921111) assessing tofacitinib for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

These Unapproved Drugs Were Affected by the FDA's Latest Seizure

Over $11.1 million worth of unapproved drugs have been seized by the U.S. marshals per request of the FDA and the U.S. Attorney for the Southern District of Ohio.

Phototherapy vs. Biologics for Psoriasis: Which is More Cost Effective?

Mean adjusted annual health care costs associated with newly diagnosed psoriasis exceeds $4,000.

Tofacitinib Meets Endpoints in Two Phase 3 Psoriasis Trials

Pfizer announced top-line results from two pivotal Phase 3 trials, evaluating the efficacy and safety of Xeljanz (tofacitinib) for the treatment of moderate-to-severe plaque psoriasis.

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

Phototherapy for Psoriasis: Understanding UV Therapy

Understanding the treatment options and related side effects of UV therapy can guide the right therapeutic choice for patients with psoriasis.

Emergency Burn Gel to Return to Retail Shelves

Quest Products has announced that it will now distribute Alocane Emergency Burn Gel (Lidocaine HCl 4%), a topical gel for pain and itch relief.

New Fast-Acting Antifungal Cream Launched

Valeant announced that Luzu (luliconazole) Cream is now available.

Sentinel-node Biopsy Succeeds in Early Melanoma Spread Detection

Research on a technique for detecting the earliest spread of melanoma has confirmed that the procedure significantly prolongs patients' survival rates compared with traditional watch-and-wait techniques.

Mederma PM Intensive Overnight Scar Cream Launched

Merz Pharmaceuticals announced the launch of Mederma PM Intensive Overnight Scar Cream (dimethicone 2%), a new cream designed to work at night.

Guselkumab Shows Improvement in Plaque Psoriasis

Janssen R&D announced results from X-PLORE, a Phase 2b study of guselkumab (CNTO 1959) in patients with moderate to severe plaque psoriasis.

Otezla Shows Improvement in Plaque Psoriasis Studies

Celgene announced the release of new research findings on Otezla (apremilast), a selective inhibitor of phosphodiesterase 4 (PDE4), from the ESTEEM 1 and 2 Phase 3 studies in patients with moderate to severe plaque psoriasis.

Xeljanz Demonstrates Efficacy in Chronic Plaque Psoriasis

Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Positive Results Announced for Rosacea Treatment

Galderma announced results from two Phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of papulopusular rosacea.

Infantile Hemangioma Treatment Approved

Pierre Fabre Dermatologie has received FDA marketing approval of Hemangeol (propranolol HCl) oral solution for the treatment of proliferating infantile hemangioma requiring systemic therapy.

Positive Retrospective Analysis Results for Talimogene for Melanoma

Amgen announced results from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene reduced the size of injected tumors and non-injected metastasized tumors.

Resistant Strain of Head Lice Prevalent in North America

Widespread use of pyrethrins- or pyrethroid-based products appears to have resulted in selection pressure for a highly-resistant strain of human head lice in North America.

Nivolumab May Improve Survival in Advanced Melanoma

For patients with advanced melanoma, nivolumab may improve overall survival and has an acceptable long-term safety profile.

Indoor Tanning Common Among High School Students

Indoor tanning is common among high school students and is linked to engaging in other risky behaviors.

Excessive Tanning Could Reflect Psychiatric Distress

Excessive tanning may indicate the presence of psychiatric distress.

High-Dose Vitamin Beneficial in Chronic Urticaria

Adjuvant high-dose vitamin D3 is beneficial for patients with chronic urticaria.

New Strength of Minocin Caps Available

Onset Dermatologics announced the launch of Minocin (minocycline HCl) 75mg pellet-filled capsules, a new dosage strength for Minocin.

More Older Men Have Skin Exams After Watching Educational Video

Older men are more likely to have a whole-body skin exam done by their physician if they watch a video on skin self-examination and skin awareness.

Teledermatology Is Reliable for Initial Triage Consultations

Teledermatology is reliable for initial triage of patients, according to a study published online.

Tretin-X Cream Available for Acne Treatment

Onset Dermatologics announced the availability of Tretin-X (tretinoin) Cream 0.075%. Tretin-X Cream is indicated for the topical treatment of acne vulgaris.

New Retin-A Micro Gel Strength Approved

FDA has approved Retin-A Micro (tretinoin; Valeant) gel microsphere 0.08%, a new strength of Retin-A Micro gel.

Nonmelanotic Invasive Skin Cancer Tied to Agent Orange

Agent Orange (2,3,7,8-tetrachlorodibenzodioxin) exposure is associated with increased incidence of nonmelanotic invasive skin cancer.

Mirvaso Shows Positive Long-Term Study Results

Galderma has announced that in a one-year, open-label, non-comparative study, Mirvaso (brimonidine) topical gel was demonstrated to be safe and effective when used once daily for up to 12 months.

Botanical Extracts May Aid in Lightening Hyperpigmentation

Botanical extracts may be helpful in the treatment of hyperpigmentation, although identification of hyperpigmentation subtype may be important for treatment prognosis.

Cure for Baldness on the Horizon?

Scientists might be able to offer "hair-challenged" males a new glimmer of hope when it comes to reversing baldness.

FDA to Review MPI-2505 NDA for RA, Psoriasis

Medac Pharma announced that the FDA has accepted for review its New Drug Application (NDA) for its lead product candidate MPI-2505 (methotrexate).

Lasers May Aid in Treatment of Onychomycosis

Lasers may be a promising treatment for onychomycosis but larger studies are needed to determine optimal treatment conditions.

Higher Melatonin, Lower Prostate CA Risk?

Men with higher levels of melatonin may have a lower risk of developing prostate cancer.

Otrexup Injection Launched for RA, Psoriasis

Antares Pharma announced the availability of Otrexup (methotrexate for subcutaneous injection) for once-weekly self-administration with a single-dose disposable auto-injector.

Biomarker Identified in Systemic Sclerosis Predicts Progression

Patients with systemic sclerosis have elevated levels of CXCL4, which predicts disease risk and progression.

Minimally Invasive Treatment Temporarily Improves Acne

A single facial fractional radiofrequency microneedle (FRM) treatment temporarily reduces sebum secretion and reduces acne severity.

Stage III/IV Melanoma Patients at Risk for New Primaries

A higher incidence of new primary melanomas was observed in patients with Stage III/IV melanoma who were male or who had a history of multiple primary melanomas.

Review Confirms Benefit of Laser Tx for Hypertrophic Scars

Laser therapy is safe and effective for hypertrophic scar management.

AAD Issues Top Five Choosing Wisely Recommendations

The top five dermatology-related issues that physicians and patients should question have been released by the American Academy of Dermatology (AAD) as part of the Choosing Wisely campaign.

Varithena Approved for Varicose Veins Treatment

BTG plc announced that the FDA has approved Varithena (polidocanol injectable foam) for the treatment of patients with incompetent veins and visible varicosities of the great saphenous vein (GSV) system.

Unemployment Linked to Accelerated Biological Aging

Young adult men who are unemployed for long periods have shorter telomeres, a sign of accelerated biological aging.

3D Imaging Captures Changes in Port Wine Stains

Three-dimensional (3D) high precision surface imaging can be used to monitor changes in the area and volume of port wine stains following laser treatment.

Interim Overall Survival Results Announced for T-VEC in Melanoma Study

Amgen announced interim overall survival (OS) results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC, or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).

Luzu Cream Approved for Skin Fungal Infections

Valeant announced that the New Drug Application for Luzu (luliconazole) Cream, 1% has been approved by the FDA.

FDA Addresses Improper OTC Topical Antiseptic Use

The FDA is requesting label and packaging changes to improve the safety of certain over-the-counter (OTC) topical antiseptic products.

Twin Study Shows Smoking Causes Premature Facial Aging

Visual evidence in identical twins shows that smoking hastens facial aging, particularly in the middle and lower thirds of the face.

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