Advisory Panel Recommends Approving Biosimilar of Remicade

Celltrion announced that the Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of all indications for CT-P13, a biosimilar candidate of Remicade (infliximab; Janssen Biotech).

New Topical Steroid Approved for Plaque Psoriasis

Dr. Reddy's announced that Promius Pharma has received approval for Sernivo (betamethasone dipropionate) Spray 0.05% for the treatment of mild to moderate plaque psoriasis in patients aged ≥18 years.

New Oral Rosacea Drug Gains Tentative FDA Approval

Dr. Reddy's Laboratories announced that the Food and Drug Administration (FDA) has granted tentative approval for Zenavod (doxycycline) capsules for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adults.

BLA for Adalimumab Biosimilar Accepted for Review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

BLA for New Plaque Psoriasis Tx Under FDA Review

Valeant, in partnership with AstraZeneca, announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for brodalumab injection for patients with moderate-to-severe plaque psoriasis.

Cosentyx Gains Two New Arthritis Indications

Novartis announced that the Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of adults with active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA).

Granulex Aerosol Spray Discontinued

The Food and Drug Administration (FDA) informed that Granulex Aerosol Spray (trypsin, balsam peru, castor oil; Mylan) has been discontinued due to market conditions.

FDA: Watch for Eye, Skin Injuries with Laser Pointers

The Food and Drug Administration (FDA) is alerting healthcare professionals about possible eye and skin injuries from exposure to laser-containing products.

FDA Proposes Tanning Bed Restrictions, Including Age Limits

The Food and Drug Administration (FDA) has proposed steps to prevent the use of sunlamp products by minors and to reduce the risk of these devices for adults.

New Treatment for Rosacea Launched

Bayer HealthCare announced the launch of Finacea Foam (azelaic acid) 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Topical Combo Treatment Approved for Plaque Psoriasis

Leo Pharma announced that Enstilar (calcipotriene and betamethasone dipropionate) foam has been approved for the topical treatment of plaque psoriasis in adults aged ≥18 years.

Complete Response Letter Issued for Xeljanz on New Indication

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate; Pfizer) for the treatment of adults with moderate to severe chronic plaque psoriasis.

New Findings for Plaque Psoriasis Tx Otezla Presented

Celgene announced that new findings from its ongoing Phase 3 LIBERATE trial evaluating Otezla (apremilast) in patients with moderate to severe plaque psoriasis were presented at the 24th European Academy of Dermatology and Venereology (EADV) Congress.

FDA Grants Avelumab Fast Track Status for Aggressive Skin Cancer

The Food and Drug Administration has granted avelumab (Pfizer/Merck) Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.

Rash and Fever in Adults Could Indicate Rare But Deadly Disease

Skin rashes accompanied by a fever could be indicative of serious or life-threatening illness in adults and warrant immediate medical attention, according to a lecture to be presented at the American Osteopathic Association's Annual Osteopathic Medical Conference and Exposition (OMED).

Novel Combination Treatment Approved for Unresectable or Metastatic Melanoma

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma.

Depression Screening Recommended for Psoriasis Patients

Psoriasis patients, regardless of disease severity, may be at an increased risk of depression, according to a study recently published in JAMA Dermatology.

FDA Designates Avelumab Orphan Drug for Skin Cancer

The FDA has granted Orphan Drug designation to the investigational cancer immunotherapy avelumab (Pfizer/Merck) for the treatment of Merkel cell carcinoma (MCC).

Vinegar May Be an Effective Alternative Against Bacteria in Burn Wounds

The active ingredient in household vinegar was effective in preventing infections and killing bacteria present in burn wounds, a new study has found.

Nalbuphine ER: Promising Study Results for Uremic Pruritus

Trevi Therapeutics announced statistically significant results from its Phase 2/3 trial of Nalbuphine ER for the treatment of moderate to severe uremic pruritus.

OTC Laser Tx for Male Baldness to Be Evaluated in Study

Theradome announced that it has initiated one of the most comprehensive studies to date to evaluate its Theradome LH80 PRO Laser Helmet on men with thinning hair or who are showing signs of balding.

FDA Accepts Keytruda sBLA for First-Line Melanoma Indication

The Food and Drug Administration (FDA) has accepted for review the sBLA for Keytruda (pembrolizumab, Merck) for the first-line treatment of unresectable or metastatic melanoma patients.

FDA: Reports of Severe Allergic Reactions with Picato

The Food and Drug Administration (FDA) is warning about reports of severe allergic reactions and herpes zoster associated with the use of Picato (ingenol mebutate topical gel).

What Tests, Txs May Be Unnecessary in Dermatology?

The American Academy of Dermatology has issued new recommendations regarding potentially unnecessary dermatologic tests and treatments as part of the Choosing Wisely campaign.

Treatment-Resistant Lice Common Across the U.S.

Treatment-resistant lice with one or more genetic mutations have been identified in at least 25 states, according to research presented at the 250th National Meeting & Exposition of the American Chemical Society (ACS).

Epiduo Forte Gel Now Available for Acne Vulgaris

Galderma announced the launch of Epiduo Forte (adapalene and benzoyl peroxide) Gel for the once-daily, topical treatment of acne vulgaris.

Systemic Therapies for Pediatric Psoriasis Compared

The safety and efficacy of biologics in the treatment of pediatric psoriasis were demonstrated in several case studies published in the Journal of Drugs in Dermatology.

Physical Trauma Ups Psoriatic Arthritis Risk

Psoriasis patients who experience physical trauma have an increased risk of developing psoriatic arthritis, according to a study presented at the European League Against Rheumatism Annual Conference (EULAR 2015) in Rome.

Greater Patient Satisfaction Seen With Biologics for Psoriasis

Patients taking biologic medications are more satisfied with their treatment and prefer longer dosing intervals compared to those taking other types of medicines for moderate to severe plaque psoriasis, reports a study in Patient Preference and Adherence.

Galderma Launches Two New Acne Mask, Cleanser Products

Galderma announced the launch of two new additions to the Benzac Acne Solutions product line: Benzac Skin Refining Mask and Benzac Acne Eliminating Cleanser.

Finacea Foam Approved for Rosacea

Bayer HealthCare announced that the Food and Drug Administration (FDA) has approved Finacea (azelaic acid) Foam 15% for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea.

FDA Warns Against Harmful Ingredient in Black Henna Tattoo Ink

The Food and Drug Administration (FDA) is warning that black henna tattoos may cause harmful skin reactions in some people.

Arthritis Drug May Help Eczema Patients, Too

A drug used to treat rheumatoid arthritis (RA) was effective in patients with moderate to severe eczema, according to a study conducted by researchers from Yale School of Medicine.

New Antibiotic-Free Acne Gel Approved

Galderma announced that the Food and Drug Administration (FDA) has approved Epiduo Forte (adapalene and benzoyl peroxide) Gel 0.3%/2.5% for the once-daily topical treatment of acne vulgaris.

Survey: Significant Education Needed for Psoriasis Patients, Clinicians

At the recent 4th World Psoriasis & Psoriatic Arthritis Conference, the International Federation of Psoriasis Associations (IFPA) released the results of a global survey on significant unmet needs on the impact of psoriasis.

Review: Acupuncture as Primary Tx for Skin Disorders

In a systematic review, acupuncture was found to improve outcome measures in the treatment of dermatitis, cholasma, pruritus, urticaria, hyperhidrosis, and facial elasticity.

Probiotics May Help Reduce Sepsis Risk in Burn Patients

Patients who had suffered severe burns were found to have a huge increase in Enterobacteriaceae and a decrease in beneficial bacteria, according to a study published in PLOS ONE.

Guselkumab May Clear Plaque Psoriasis, Shows Study

Janssen Research & Development announced results from the Phase 2b X-PLORE trial with guselkumab in patients with moderate to severe plaque psoriasis.

New Steroid-Free Options for Itch Relief Launched

Cosmederm Bioscience announced the expansion of its itch-relief product line featuring two new steroid-free, anti-itch products.

FDA: Derm Dilemma with Daytrana

The Food and Drug Administration (FDA) has issued a warning that the use of Daytrana patch (methylphenidate transdermal system; Noven) may result in permanent loss of skin color.

New Insight on ED Drugs-Melanoma Risk Link

Patients taking medications for erectile dysfunction may have an increased risk of melanoma, but these drugs are not a cause of melanoma, researchers concluded.

Black Box Warning for Potiga Reviewed Again by FDA

The Food and Drug Administration (FDA) has determined that the Boxed Warning for Potiga (ezogabine; GlaxoSmithKline) is adequate to manage the potential risks of vision loss due to pigment changes in the retina and skin discoloration.

Significant Improvement in Plaque Psoriasis Seen With Cosentyx

Novartis announced results from two clinical trials on the efficacy of Costentyx (secukinumab) for the treatment of plaque psoriasis of the palms, soles, and nails in adult patients.

FDA: Beware of Embolization With Dermal Fillers

The Food and Drug Administration (FDA) has issued an alert regarding certain injection sites on the face where unintentional injection of soft tissue fillers into blood vessels in the face can result in rare but serious side effects.

Which Tattoo Ink Colors Are Most Likely to Cause Skin Reactions?

Researchers at the NYU Langone Medical Center have reported that up to six percent of adults in New York who get tattoos have experienced some form of tattoo-related rash, severe itching, or swelling that lasted from four months up to years for some.

Humira Designated Orphan Drug for Painful, Inflammatory Skin Disease

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for Humira (adalimumab) as an investigational treatment for moderate-to-severe hidradenitis suppurativa (HS; Hurley Stage II and III disease).

Vitamin B3 May Reduce Recurrence of Some Skin Cancers in High-Risk Patients

A study presented at the American Society of Clinical Oncology's (ASCO) 51st Annual Meeting found that an over-the-counter form of vitamin B3 significantly reduced rates of new non-melanoma skin cancers in high-risk patients, which along with sun protection could help to decrease the health and economic burden of skin cancer.

Study: Anti-Itch Hydrogel Superior to OTC Creams

A study published in Clinical, Cosmetic, and Investigational Dermatology showed that TriCalm hydrogel is significantly superior to diphenhydramine 2 percent and hydrocortisone 1 percent in its antipruritic effect.

Opdivo sBLA Under Priority Review for New Melanoma Indication

The Food and Drug Administration (FDA) has accepted for filing and has granted Priority Review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.

High-Dose Creams More Effective for Genital Warts, Reports Study

A high-dose treatment of sodium nitrite and citric acid creams applied twice daily was more effective than placebo for treating anogenital warts, according to a new study in JAMA Dermatology.

New OTC Ointment Launched for Shingles Relief

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.

Investigational Malignant Melanoma Therapy Granted Orphan Drug Status

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.

Counterfeit Botox Discovered in the U.S.

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.

Samcyprone Designated Orphan Drug for Malignant Melanoma

The FDA has granted Orphan Drug designation to Samcyprone (diphenylcylcopropenone, DPCP; RXi Pharmaceuticals) for the treatment of malignant melanoma Stage IIb to IV.

No More Latex-Free Claims, Recommends FDA

The Food and Drug Administration (FDA) is recommending that manufacturers stop using the labels "latex-free" or "does not contain latex" due to the scientific inaccuracy of these claims.

Keytruda Results May Halt Melanoma Trial Early

Merck announced results from the Phase 3 KEYNOTE-006 study investigating Keytruda (pembrolizumab) vs. ipilimumab in the first-line treatment of patients with advanced melanoma.

New Data Shows Tofacitinib Effective for Plaque Psoriasis

Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Long-Term Efficacy Data for Otezla in Plaque Psoriasis Announced

Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.

Acne Medication Rxs Often Go Unfilled, Says New Survey

Over 25% of patients with acne did not obtain medications prescribed by their dermatologists, according to a survey by Wake Forest Baptist Medical Center researchers.

Combo Acne Drug Reduces Lesion Count in Trial

Galderma announced positive Phase 3 results for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel.

Two Older Antibiotics Effective Against Community-Acquired MRSA, Says New Research

Two common antibiotics have been shown to be equally effective in treating uncomplicated community-acquired skin infections like methicillin-resistant Staphylococcus aureus (MRSA), according to a new study in the New England Journal of Medicine.

Adding BP Drug May Lessen Topical Steroid Side Effects

An antihypertensive was found to reduce side effects from corticosteroid-based creams used for certain skin diseases, reports a study published in the Journal of Investigative Dermatology.

Smart Bandage Could Prevent Bed Sores With Early Detection

A new "smart bandage" has been developed that can detect early tissue damage from pressure ulcers before they are visible to the human eye.

Psoriasis Symptoms Improve After Single Dose of Experimental Antibody Tx in Study

Patients with moderate-to-severe psoriasis showed significant recovery after a single dose of an experimental human antibody treatment that targets interleukin-23, a study showed.

First Biosimilar Product Approved by the FDA

The Food and Drug Administration (FDA) has approved the first biosimilar product, Zarxio (filgrastim-sndz; Sandoz).

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.

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.

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.

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.

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