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FDA, EMA Accept Galderma’s BLA for Nemolizumab for PN and AD

The Dermatology Digest

Food and Drug Administration (FDA) has accepted Galderma’s Biologics License Applications for nemolizumab for the treatment of patients with prurigo nodularis (PN) and for adolescents and adults with moderate to severe atopic dermatitis (AD). Galderma is planning for multiple regulatory submissions in 2024.

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FDA Clears IND Application for InnoCare’s TYK2 Inhibitor

The Dermatology Digest

Food and Drug Administration (FDA) has cleared InnoCare Pharma’s investigational new drug application (IND) for ICP-332, a tyrosine kinase 2 (TYK2) inhibitor that’s being studied in moderate to severe atopic dermatitis (AD). Currently, no TYK2 inhibitors have obtained marketing approval for the treatment of AD.

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Mount Sinai Awarded $6.6M NIH Grant to Study Dupilumab in Pediatric AA

The Dermatology Digest

This grant will fund a collaborative effort to investigate the safety, tolerability, efficacy, and durability of response of subcutaneous administration of dupilumab in pediatric patients with extensive alopecia areata, defined as affecting at least 30% of the scalp.

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Oh, The Places Dermatology Will Go in 2024!

The Dermatology Digest

In 2023, dermatologists and their patients welcomed new drugs for acne, psoriasis, alopecia areata, and more, and 2024 promises to deliver real-world data on these medications along with even more therapeutic innovations across the spectrum of cutaneous diseases. The BIG story is Janus kinase ( JAK ) inhibitors,” Dr. Martin says.

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And the Winners Are…PeDRA Announces 2023 Grant Recipients

The Dermatology Digest

The 2023 PeDRA Research Grant recipients are: Joyce Teng, MD, PhD of Stanford University, will conduct a project titled “ A Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of a Hypertonic Gel in the Treatment of Pediatric Cutaneous Pyogenic Granuloma.

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Meet the 2023 NEA Grant Winners

The Dermatology Digest

Ofir Cohn PhD , Boston Children’s Hospital, Boston, MA Deciphering how genetic variation associated with risk of eczema impacts human dendritic cell subset function Liwen Deng BS, PhD , President & Fellows of Harvard College, Boston, MA S. in subsequent National Institutes of Health (NIH) funding to support further research.

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Topline Phase 1 Trial Results for Apogee’s APG777 in AD “Exceed Expectations”

The Dermatology Digest

Pharmacokinetic (PK) data showed a half-life of approximately 75 days across doses tested and pharmacodynamic (PD) data showed, deep and sustained inhibition of key atopic dermatitis (AD) biomarkers pSTAT6 and TARC for ~3 months (longest follow-up available, with inhibition still ongoing at time of the data cut).