Otezla Now Approved for Plaque Psoriasis Across All Severities
The approval was based on data from the phase 3 ADVANCE trial.
The approval was based on data from the phase 3 ADVANCE trial.
The application is supported by data from the phase 3 TRuE-V clinical trial program.
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.
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.
The FDA’s Fast Track process allows for expedited review of drugs that are expected to fill an unmet need.
The approval of Winlevi was based on data from 2 double-blind, vehicle-controlled phase 3 trials in 1440 patients with facial acne vulgaris.
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.
The interchangeable biosimilar product may be substituted for the reference product by a pharmacist.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that selectively inhibits both interleukin (IL)-17A and IL-17F.
The modified iPLEDGE REMS will go into effect starting December 13, 2021.