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September 15, 2025
Article
The US Food and Drug Administration has approved bumetanide nasal spray for the treatment of edema in outpatient heart, liver, and kidney diseases.
The label update expands the treatment eligible population to include dystrophic epidermolysis bullosa patients from birth and allows at-home application.
September 11, 2025
Intercept Pharmaceuticals has voluntarily withdrawn obeticholic acid from the US market following a request from the FDA.
September 10, 2025
Upon further review of the sNDA, the Agency indicated an advisory committee for sparsentan in FSGS is no longer needed.
September 09, 2025
For the first time, the FDA has accepted the initiation of the qualification of an NIT as a noninvasive surrogate endpoint in drug development for MASH.
September 08, 2025
The first patient in the ongoing Multi-Patient Expanded Access study has surpassed 7 months kidney function, and a second patient has been successfully transplanted.
Lexicon aims to address concerns from a 2024 complete response letter, which cited an increased risk of diabetic ketoacidosis.
September 07, 2025
Podcast
Explore the latest advancements in diabetes technology, including FDA-approved insulin pumps and innovative CGMs for weight management.
September 06, 2025
FDA expands Vonvendi approval for all von Willebrand disease types, enhancing treatment options for adults and children with this rare condition.
September 04, 2025
Agios announces a 3-month extension for mitapivat's FDA review.
