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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. immunology market.” “STEQEYMA is now the latest biologic in our immunology portfolio, joining ZYMFENTRA (infliximab-dyyb). .

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PHysicians & the esthetician

Southeastern Esthetics Institute

Having a thorough understanding of the dermatology and plastic surgery procedures, in addition to all new and modern cosmetic procedures on the market, is critical in assisting your clients in answering questions. A complete system must be in place per office, for the role of every action within the practice.

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U.S. FDA Grants Orphan Drug Designation for Restem’s ULSC Program for the Treatment of Dermatomyositis and Polymyositis

The Dermatology Digest

Restem’s ULSC therapy has shown promising results in early clinical trials, demonstrating safety, tolerability and initial clinically significant improvements, as well as the potential to significantly reduce the need for steroid use in patients. The company is currently preparing for Phase 2/3 trials with anticipated initiation in 1Q 2025.

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U.S FDA Approves Mirdametinib (Gomekli, SpringWorks) for Adult and Pediatric Patients With NF1-PN

The Dermatology Digest

It was very encouraging in the ReNeu trial to see that Gomekli provided deep and durable responses, with a manageable safety profile that enabled patients to stay on therapy. Gomekli demonstrated a manageable safety and tolerability profile.

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Dermata Phase 3 Acne Trial Update: Last Patent Completes Last Visit in Trial of Freshwater Sponge-based Treatment

The Dermatology Digest

This is a great milestone for our team, as we continue to examine the acne market, we believe there is still a high unmet need by patients for an acne product like XYNGARI, says Gerry Proehl, Dermatas Chairman, President, and Chief Executive Officer, in a news release.

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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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HS Pipeline Watch: MoonLake Immunotherapeutics’ Sonelokimab Heads to Phase 3

The Dermatology Digest

Marketing Authorization Application. About the MIRA trial The MIRA trial (M1095-HS-201) is a global, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of the Nanobody sonelokimab, administered subcutaneously, in the treatment of adult patients with active moderate-to-severe hidradenitis suppurativa.

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