March 12th 2025
Two companies have received approved for a generic of the 2.5 mg tablet of anticoagulant rivaroxaban, which is used to reduce the risk of stroke and deep vein thrombosis.
FDA Accepts sNDA for Foam Psoriasis Drug Zoryve
September 24th 2024The FDA has already approved Zoryve cream (0.3% and 0.15%) for plaque psoriasis and atopic dermatitis in adults and children ages 6 and up. Currently, Zoryve foam 0.3% is only approved to treat seborrheic dermatitis in adult and pediatric patients 9 years and older.
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FDA Expands Bimzelx Approval to Three Additional Autoimmune Indications
September 23rd 2024Bimzelx was first approved last year for the treatment of moderate to severe psoriasis in adults, making it the first and only IL-17A and IL-17F inhibitor approved in the United States for four autoimmune diseases.
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FDA Assigns Review Date for Mirdametinib in Genetic Neuro-Oncology Condition
August 28th 2024The FDA has given mirdametinib a Prescription Drug User Fee Act (PDUFA) action date of Feb. 28, 2025, to treat patients with neurofibromatosis type 1 with tumors that grow along the peripheral nerve.
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