Hepatitis B immune globulin (human) (Nabi-HB, Nabi Bio-pharmaceuticals) for the treatment of hepatitis B infection
Recommendations for approval
Approvable designations
Fast-track designations
Orphan drug designations
Non-approvable designations
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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ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
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