April 21st 2025
The complete response letter did not identify any issues with the safety or efficacy of Eylea HD, Regeneron officials said.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
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AstraZeneca, Daiichi Sankyo Submit New BLA for Datopotamab in Lung Cancer
November 12th 2024After feedback from the FDA, the companies have voluntarily withdrawn the previous biologics licensing application for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous non-small cell lung cancer.
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FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
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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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