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PDUFA Delay: FDA Asks for More Information From Abeona for Pz-cel Market Application

The Dermatology Digest

The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel. The BLA for pz-cel was accepted for filing and granted priority review designation by the FDA in November 2023.

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FDA Nod for Ustekinumab Biosimilar

The Dermatology Digest

market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the U.S. In February 2023, Fresenius Kabi and Formycon entered into a global commercialization partnership for the ustekinumab biosimilar candidate covering key global markets. and worldwide.

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10 Best Nasal Sprays for COVID-19 (2023)

Aesthetics Advisor

The pharmacology, toxicity, and safety data for NO use in humans has been well-established for decades. Moreover, Glenmark Pharmaceuticals received manufacturing and marketing approval for the Nitric Oxide Nasal Spray (NONS) as part of an accelerated approval process. Iota-carrageenan is a sugar that comes from algae.

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A comment on the 2024 EWG Sunscreen Guide; Is EWG actively harming safe consumer sun protection?

The Eco Well Blog

Or are they putting these guides out as a fear marketing campaign to promote the EWG seal program (which makes them money)? 2023), when consumers had the option between “mineral” and “chemical” sunscreens, when blinded, overwhelmingly they preferred the “chemical” sunscreen. market while tests are still being conducted.

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

The Dermatology Digest

In addition, the European Medicines Agency has also accepted the Marketing Authorization Applications for nemolizumab in prurigo nodularis and atopic dermatitis. The European Medicines Agency has also accepted Galderma’s Marketing Authorization Applications for nemolizumab in both prurigo nodularis and atopic dermatitis.

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

The Dermatology Digest

The treatment was approved by the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe AD in additional European markets, including the United Kingdom and Switzerland in 2024.

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The Current State of Animal Testing in Beauty - Blog Version

The Eco Well Blog

There is so much misinformation about animal testing in the beauty sector, and a lot of opportunistic, probably predatory, marketing to take advantage. The dark history of Cosmetics Safety From the 18th century’s use of lead carbonate in makeup to the use of radium in the 1920s and 30s, there have been many deaths in the name of beauty.

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