6 FDA Decisions Expected Before 2024
From a novel acne cream to a breakthrough depression drug, a half-dozen agent decisions are coming through in the coming 6 months.
Microencapsulated Benzoyl Peroxide Rapidly, Significant Improves Rosacea
Analysis of a novel form of the topical drug shows rosacea is benefitted within 2 weeks of daily administration.
Ixekizumab Linked to Low Risk of Major Cardiovascular Events in Psoriatic Patients
An analysis of patients with psoriasis, PsA, or axSpA show risk of MACE with ixekizumab is consistently low.
FDA Issues Complete Response Letter for Aflibercept 8 mg as AMD, DME Treatment
The letter makes reference to an ongoing review of inspection findings from a third-party filler involved with the drug development. Regeneron will not require additional trial data.
FDA Approves Ritlecitinib as First Drug for Adolescent Alopecia Areata
Ritlecitinib becomes the second JAK inhibitor approved to treat alopecia—and the first to be indicated for patients aged 12 years and older.
Tazarotene Lotion Benefit for Acne Does Not Differ by Season
Post hoc analysis of the topical therapy show patients receiving treatment for acne in the winter were as likely to achieve benefit as those receiving it in the summer.
Secukinumab Significantly Improves Hindradenitis Suppurativa Regardless of Demographics
A post hoc analysis of phase 3 adds support to the IL-17A inhibitor for the potential treatment of HS.
Dawn Eichenfield, MD: Identifying Allergies in Pediatric Dermatology
While contact dermatitis is difficult to distinguish in children, there has become a greater collaboration between allergic and dermatologic specialists in managing conditions like atopic dermatitis.
Hilary Baldwin, MD: IDP-126 May Change Acne Management
The first triple-combination topical drug for acne may be available by the end of this year. One expert has high hopes for it.
Matthew Zirwas, MD: Ruxolitinib Cream and the Eczema JAK Inhibitor Era
Zirwas touts topical ruxolitinib's rapid, effective treatment of atopic dermatitis, and reviews the safety outcomes associated with JAK inhibitors.
Amit Pandya, MD: The Discovery of Oral Tranexamic Acid for Melasma
Pigmentary disorders including melasma are difficult to treat and complex. The leading agent for one expert was uncovered by unique circumstances.
Dawn Eichenfield, MD: Tips for Managing Severe Acne
From addressing the rare acne fulminans to utilizing narrow-spectrum antibiotics, the modern field of acne treatment is more complicated than it seems.
Baricitinib Consistently Safe, Tolerable for Severe Alopecia Areata at 2 Years
Analysis of phase 3 trial data show the JAK inhibitor is generally safe among patients with severe forms of the chronic hair loss disease.
Hilary Baldwin, MD: The Surge of Rosacea Treatment Options
In the span of a decade, agents like topical ivermectin, minocycline and benzoyl peroxide has provided more opportunities to achieve clear skin for rosacea patients.
Amit Pandya, MD: Ruxolitinib Cream in Real-World Vitiligo Patients of Color
The trial investigator reviews disparities in patient needs and treatment outcomes based on their skin complexion, 1 year after ruxolitinib's FDA approval.
Melodie Young, MSN, ANP-c: Managing Comorbid Psoriatic Disease
Often lost in the fray of new drug development is the need to reinforce improved behavioral health, explains a longtime dermatology nurse practitioner.
Matthew Zirwas, MD: How Tapinarof Could Address Adult-Onset Atopic Dermatitis
On the basis of discovery into what drives adult-onset eczema, the novel drug may provide a unique benefit for impacted patients.
Nemolizumab Rapidly Improves EASI, SCORAD Scores for Atopic Dermatitis
A post hoc analysis shows the investigative drug significantly improved atopic dermatitis symptoms versus placebo as soon as the first week into a phase 2 trial.
Melodie Young, MSN, ANP-c: Keeping up with Dermatology's Advances
It's been a whirlwind few years for dermatology. The nurse practitioner discusses modern care teams, comorbid psoriatic disease, and expanding patient inclusion in clinical trials.
Albert Yan, MD: Navigating Advances to Acne Therapies, Monitoring
Yan discusses how acne care strategies have been bolstered—and complicated—by pharmacotherapy and telemedicine developments.
Matthew Zirwas, MD: How Do Emerging HS Treatments Line Up?
With multiple drug classes working toward FDA indication, a dermatologists explains his strategy for managing hidradenitis suppurativa.
Tapinarof Cream Tolerable, Safe in Pediatric Patients with Atopic Dermatitis
The first trial observing the topical drug in children held promise for an extended indication.
Albert Yan, MD: Detecting Pediatric Skin Disease with the Microbiome, Technology
The CHOP pediatric dermatology director reviews recent breakthroughs in understanding complex pathophysiology of skin diseases.
Matthew Zirwas, MD: Roflumilast Foam for Seborrheic Dermatitis
The investigator explains why he believes the PDE4 inhibitor is "as close to a perfect drug as you can hope for in seborrheic dermatitis."
Depression Diagnoses More Common Among Younger, Female Americans
New CDC survey data show an estimated 47 million adults in the US have ever been diagnosed with depression, with clear disparities based on demographics and regions.
FDA Discourages Self-Diagnosing, Treating Molluscum as Drug Decision Dates Approach
With a pair of novel drugs seeking FDA approval for the common skin infection, the agency stresses avoiding misleading products currently on the market.
Lung Cancer Detection & Treatment with Dr. Carolyn Presley
A geriatric expert, Presley provides a poignant point-of-view on the need for a multidisciplinary approach to patient care, as well as advances in treatment that include targeted therapies.
FDA Approves Odevixibat for Cholestatic Pruritus in Alagille Syndrome
The approval makes odevixibat the second IBAT inhibitor approved for the rare genetic disease, with capability to benefit both liver damage and itch symptoms.
Michael C. Cameron, MD: Reflecting on Real-World Abrocitinib
An investigator argues for greater prescriber understanding and communication of real-world efficacy and safety outcomes for the latest oral JAK inhibitor approved for atopic dermatitis.
Jennifer Hsiao, MD: JAK Inhibitors for Hidradenitis Suppurativa
Oral JAK-1 inhibitors upadacitinib and povorcitinib are showing significant benefit for patients with HS, and may soon be up for FDA decision.
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