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U.S. FDA Approves Celltrion’s STELARA Biosimilar

The Dermatology Digest

The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. “STEQEYMA is now the latest biologic in our immunology portfolio, joining ZYMFENTRA (infliximab-dyyb). . immunology market.”

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FDA Nod for PYZCHIVA (ustekinumab-ttwe), Samsung Bioepis’ Stelara Biosimilar

The Dermatology Digest

The FDA’s approval of PYZCHIVA is based on a totality of evidence including analytical, non-clinical and clinical data demonstrating biosimilarity to Stelara, with no clinically meaningful differences in terms of safety, purity and potency. PYZCHIVA, developed by Samsung Bioepis, will be commercialized by Sandoz in the United States.

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PHysicians & the esthetician

Southeastern Esthetics Institute

Specific courses for cosmetic lasers, for example, are crucial to add to the esthetics portfolio, in order to showcase added training beyond that of the esthetics fundamentals course. Esthetics practitioners within any advanced setting should obtain certifications underneath their license for each individual advanced procedure.

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FDA Approves JUVÉDERM VOLUMA XC for Filling Temple Hollows

The Dermatology Digest

The Allergan Medical Institute (AMI) team can train aesthetic providers on safe and effective treatments using the Allergan Aesthetics portfolio to address 90% of the face. The post FDA Approves JUVÉDERM VOLUMA XC for Filling Temple Hollows appeared first on The Dermatology Digest.

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TDD Industry News and Views: Weekly Updates on Comings, Goings, and Other Happenings in Dermatology in the U.S. and Abroad

The Dermatology Digest

“China has always been a strategic market for Sisram, and the approval of Daxxify serves as a key milestone for bringing Sisram’s high-end injectables portfolio to Mainland China,” says Mr. Liu Yi, Sisram Chairman and Executive Director, in a news release. and Abroad appeared first on The Dermatology Digest.

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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. Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to Stelara in patients with moderate to severe psoriasis vulgaris. and worldwide.

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

The Dermatology Digest

The Phase 1 trial is a first-in-human, randomized, double-blind, placebo-controlled study designed to evaluate the safety and PK of APG777 in healthy volunteers. The study enrolled 40 healthy adult participants into three single-ascending dose (SAD) and two multiple-ascending dose (MAD) cohorts.