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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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Evolus Scores EU Approval of Estyme Injectable Hyaluronic Acid Gel Fillers Under New Medical Device Regulation Process

The Dermatology Digest

The EU Medical Device Regulation (MDR) certification gave its nod to four injectable hyaluronic acid (HA) gel fillers from Evolus under the brand name Estyme, The CE Mark certification, through the new MDR process, represents more stringent requirements, designed to ensure the safety, efficacy, and quality of medical devices sold in Europe.

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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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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 post FDA OKs Emergent’s mPox Vaccine 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.