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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.”
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.
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.
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.
“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.
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.
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.
Next up, we’ll be tackling the topic of safety, coming your way in late September. serves as Environmental Scientist at Personal Care Products Council (PCPC) and focuses on assessing the environmental safety of cosmetics and personal care ingredients. This was our attempt to democratize accurate information for the cosmetics industry.
She is also an adjunct professor in the Department of Dermatology at the Keck School of Medicine of the University of Southern California. Her area of clinical expertise is in complex medical dermatology, skin cancer, and acne. Carl presented at the Sunscreen E-Summit on behalf of DSM.
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.
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.
Apogee Therapeutics recently hosted its first R&D Day, which featured updates across its entire portfolio. The post Inside the Apogee Pipeline: Company Shares Updates on APG777 and APG990 for AD appeared first on The Dermatology Digest. Stay tuned.
This milestone represents an exciting new chapter in our long-term strategy to expand our portfolio and transition from a single-product company to a multi-product innovator, strengthening our leadership in performance beauty, says David Moatazedi, President and Chief Executive Officer of Evolus, in a news release. s Evolyssecollection.
have entered into a collaboration and licensing agreement to develop, manufacture, and commercialize ESK-001, a highly selective, next-generation oral tyrosine kinase 2 (TYK2) inhibitor, for dermatology indications in Japan, with the option to expand the license to include rheumatological and gastrointestinal diseases. Alumis Inc.
The data highlight the efficacy of the cream, along with its favorable safety and tolerability profile, which are critical when prescribing a long-term treatment for children with AD, says Mercedes E. In clinical trials, investigational ZORYVE cream 0.05% has shown significant positive results in treating AD in children 2 to 5 years old.
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