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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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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

Additionally, more than 85% of clinical trial subjects were satisfied with how balanced, well-proportioned, and symmetric their face looked three months after treatment. 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.

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FDA OKs Emergent’s mPox Vaccine

The Dermatology Digest

The approval is based on previously available human safety data and data from a well-controlled animal study in which ACAM2000 vaccine was shown to be effective in protecting against mpox virus exposure. The clade I variant of mpox is characterized by more severe clinical outcomes and a higher case fatality rate.

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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. The approval is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data. and worldwide.

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

The Dermatology Digest

APG777 is the first clinical-stage product candidate from the company’s strategic collaboration with Paragon Therapeutics, Inc. Based on these data, the company plans to initiate a randomized, placebo-controlled, Phase 2 clinical trial in patients with moderate-to-severe AD in the first half of 2024 ahead of schedule.

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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.