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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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U.S. FDA Approves Celltrion’s STELARA Biosimilar

The Dermatology Digest

Food and Drug Administration (FDA) has approved STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis. immunology market.”

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FDA Approves JUVÉDERM VOLUMA XC for Filling Temple Hollows

The Dermatology Digest

Food and Drug Administration has approved JUVÉDERM VOLUMA XC for injection in the temple region to improve moderate to severe temple hollowing in adults age 21 and older. 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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“From Novice to Expert: How Injectable Training Courses Can Elevate Your Skills.”

AAAMS

Introduction to Injectable Training Courses Injectable training courses are your fastest ticket from being a beginner to a pro in the cosmetic industry. The journey starts with understanding what injectables are – substances like Botox and fillers that enhance facial features and diminish and promote a youthful appearance.

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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

It incorporates Polyglutamic Acid (PGA), a peptide known for its hydrating properties The non-injectable Elastiderm Advanced Filler Concentrate is formulated with Acetyl Hexapeptide-1, to smooth wrinkles and add volume.

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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.

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

The Dermatology Digest

Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for PYZCHIVA (ustekinumab-ttwe) subcutaneous injection and intravenous infusion as a biosimilar to Stelara (ustekinumab). Samsung Bioepis has seven biosimilars approved in the US and four commercially available as of June 2024.