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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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Oh, The Places Dermatology Will Go in 2024!

The Dermatology Digest

Jashin Wu, MD, founder and CEO of the Dermatology Research and Education Foundation in San Diego, CA, says that more psoriasis patients will see improvements in their condition due to the influx of new agents and biosimilars on the market. It has great efficacy and safety and is oral… [This means] no shot and no risk of anaphylaxis.”

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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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What’s Really in Tattoo Ink? Study Shows Ingredient Labels May Not Be Accurate

The Dermatology Digest

Swierk noted that the research on the safety implications of tattoos is still out. Regulation of tattoo inks on the American market is very recent. The tattoo inks available in the American and European markets differ because the latter is subject to stricter regulations, overseen by the European Chemicals Agency.

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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.

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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.