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This approval by the FDA of ruxolitinib cream for children aged 2-11 years atopic dermatitis follows recent positive clinical trial findings on the treatment.

FDA Approves Ruxolitinib Cream for Pediatric Patients with Atopic Dermatitis

The US Food and Drug Administration has approved bumetanide nasal spray for the treatment of edema in outpatient heart, liver, and kidney diseases.

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

The label update expands the treatment eligible population to include dystrophic epidermolysis bullosa patients from birth and allows at-home application.

FDA Approves Beremagene Geperpavec-svdt (Vyjuvek) Label Update in DEB

Intercept Pharmaceuticals has voluntarily withdrawn obeticholic acid from the US market following a request from the FDA.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market

Upon further review of the sNDA, the Agency indicated an advisory committee for sparsentan in FSGS is no longer needed. 

FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

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.

FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials

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.

FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD

Lexicon aims to address concerns from a 2024 complete response letter, which cited an increased risk of diabetic ketoacidosis.

Lexicon Submits Additional Benefit-Risk Data to FDA for Sotagliflozin for Type 1 Diabetes

Explore the latest advancements in diabetes technology, including FDA-approved insulin pumps and innovative CGMs for weight management.

Diabetes Dialogue: Milestones for MiniMed 780G and Signos CGM for Weight Loss

FDA expands Vonvendi approval for all von Willebrand disease types, enhancing treatment options for adults and children with this rare condition.

FDA News