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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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How Contact Dermatitis Can Result from ‘Natural’ Skin Care Products

First Derm

However, it is important to address the misconception that “natural” automatically equates to safety. By addressing the misconception surrounding the safety of natural skin care products, we can better understand the need for careful evaluation and consideration when choosing these products.

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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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NICE Recommends Lebrikizumab for Moderate to Severe AD in the NHS England

The Dermatology Digest

for use in moderate to severe atopic dermatitis (AD) in the NHS England. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024. The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab.

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FDA Green Lights Leo’s Adbry for Kids With AD

The Dermatology Digest

Food and Drug Administration (FDA) has expanded the approval of tralokinumab-ldrm (Adbry, LEO Pharma Inc) to include kids aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Eczema 36
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FDA Green Lights Leo’s Adbry for Kids With AD

The Dermatology Digest

Food and Drug Administration (FDA) has expanded the approval of tralokinumab-ldrm (Adbry, LEO Pharma Inc) to include kids aged 12-17 years with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

Eczema 36
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Breaking News: Japan First in the World to Approve Dupilumab for CSU

The Dermatology Digest

The Ministry of Health, Labor and Welfare (MHLW) in Japan has granted marketing and manufacturing authorization for dupilumab (Dupixent, Sanofi and Regeneron Pharmaceuticals, Inc.) The safety profile of dupilumab in CSU was generally consistent with the known safety of Dupixent in its approved dermatological indications.