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Galderma’s Nemolizumab Approved for AD and PN in the UK and Switzerland

The Dermatology Digest

Just days after snagging dual approvals for moderate-to-severe atopic dermatitis (AD) and prurigo nodularis (PN) in the European Union, nemolizumab (Nemluvio, Galderma) was also granted Marketing Authorization in the United Kingdom (UK) and Switzerland for AD and PN.

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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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CHMP Recommends Approval of Galderma’s Nemolizumab for Moderate to Severe AD and PN in the European Union

The Dermatology Digest

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization for nemolizumab (Nemluvio. Galderma) for the treatment of both atopic dermatitis and prurigo nodularis in the European Union (EU).

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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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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