Otezla Now Approved for Plaque Psoriasis Across All Severities
The approval was based on data from the phase 3 ADVANCE trial.
Dermatological Disorders
Ruxolitinib Cream Gets Priority Review for Vitiligo Treatment
The application is supported by data from the phase 3 TRuE-V clinical trial program.
Rinvoq Approved for Active Psoriatic Arthritis
The application is supported by data from two phase 3 studies (SELECT-PsA 1 and SELECT-PsA 2) that assessed upadacitinib in adults with active PsA.
Deucravacitinib Under Review for Moderate to Severe Plaque Psoriasis
The application is supported by data from the pivotal phase 3 POETYK PSO-1 and POETYK PSO-2, which included patients with moderate to severe plaque psoriasis.
FDA Grants Fast Track Designation to Orismilast for Atopic Dermatitis
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
Acne Vulgaris Treatment Winlevi Now Available
The approval of Winlevi was based on data from 2 double-blind, vehicle-controlled phase 3 trials in 1440 patients with facial acne vulgaris.
FDA Adds Restrictions, Updates Labeling for Breast Implants
The FDA has approved new labeling requirements for all legally marketed breast implants that include a Boxed Warning, patient decision checklist, and other safety measures.
First Interchangeable Biosimilar to Humira Gets FDA Approval
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
Travel Restrictions Hinder Bimekizumab BLA Review
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
FDA Announces Modifications to iPLEDGE REMS Program
The modified iPLEDGE REMS will go into effect starting December 13, 2021.
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