FDA News

The Q3 recap for cardiology spotlights major FDA decisions, new heart failure and hypertension guidelines, and top trial results and research.

Catch up on FDA decisions, critical trial results, and expert perspectives on endocrinology.

Read about groundbreaking FDA decisions, exciting new heart failure research, and more.

The approval is supported by data from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study.

Explore key FDA decisions in Q4 2025, impacting treatments for atopic dermatitis, chronic rhinosinusitis, and rare diseases.

The first oral BTK inhibitor for CSU offers fast relief for patients uncontrolled on antihistamines and an alternative to injectable biologics.

The FDA has approved remibrutinib, a new oral treatment for chronic spontaneous urticaria, offering hope for patients unresponsive to antihistamines.

Denecimig may offer a prophylaxis bleed treatment option for a range of patients across dosing frequencies, age groups, and condition severity.

The resubmission is based on results from 5 randomized clinical trials in the ONWARDS type 2 diabetes phase 3a program.

The approval of the selectively targeted somatostatin receptor type 2 agonist is supported by data from the phase 3 PATHFNDR-1 and PATHFNDR-2 trials.

The extended indication includes children 1 to < 5 years of age with homozygous familial hypercholesterolemia.

Biolinq Shine aims to provide continuous glucose monitoring, as well as sleep and activity data, without requiring injections.

The Agency initiated an acetaminophen label change to reflect evidence of potential harms in pregnant women and an approval of leucovorin for CFD.

The approval offers the flexibility of self-administration from the start of treatment for UC, building on the prior approval of SC induction in Crohn’s disease.

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.

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.

Intercept Pharmaceuticals has voluntarily withdrawn obeticholic acid from the US market following a request from the FDA.

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

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.

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.

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

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

Agios announces a 3-month extension for mitapivat's FDA review.