Abigail Brooks, MA

The decision updates the indication statements for ulcerative colitis and Crohn’s disease to allow use in patients who have received ≥ 1 approved systemic therapy.

The sBLA for insulin human Inhalation Powder in children and adolescents with type 1 or type 2 diabetes was assigned a PDUFA target action date of May 29, 2026.

Increases in short-term kidney function decline were observed following post-COVID-19 vaccination gross hematuria in individuals with IgA nephropathy.

LUCENT-3 open-label extension study data establish mirikizumab-mrkz (Omvoh) as the first and only IL-23p19 to show sustained long-term outcomes in UC through 4 years.

High intake of both sugar-sweetened beverages and low- or non-sugar-sweetened beverages was linked to greater MASLD risk.

The Q3 recap for gastroenterology spotlights key FDA decisions, new AGA gastroparesis guidelines, and other top GI news and research.

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.

The Q3 recap for hepatology spotlights key FDA news, the withdrawal of OCA for PBC, and notable hepatic research from the past few months.

The Q3 recap for nephrology spotlights key FDA decisions, new KDIGO IgA nephropathy guidelines, and other top renal news and research.

Read about new AGA gastroparesis guidelines, GI FDA news, and more.

Read about hepatic FDA news, the voluntary withdrawal of obeticholic acid for PBC, new trial data for a potential AATD drug, and more.

Check out renal FDA news, new KDIGO guidelines on IgAN and IgAV management, research about hypertensive kidney disease, and more.

Both organizations defend the use of Tylenol during pregnancy, citing “rigorous” and “reputable” research suggesting it does not cause autism in children.

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.

Both ACOG and AAP have released statements disagreeing with the FDA label change for acetaminophen to reflect autism risk in children if used during pregnancy.

Findings from an analysis of GBD 2021 data highlight increases in the absolute number of ASCVD cases and deaths among the working-age population.

Findings suggest post-stroke dysphagia is associated with adverse psychosocial outcomes at 3 months, emphasizing the need for comprehensive rehabilitation strategies.

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

Phase 3 STRIVE-ON Safety Trial results were presented at the 2025 Neurocritical Care Society annual meeting and suggest GTx-104’s viability over oral nimodipine.

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.

The guideline offers 12 conditional recommendations for the diagnosis and management of gastroparesis, emphasizing individualized care and calling for more research.

The 2025 guideline updates previous recommendations made in the 2021 glomerular disease guideline based on recent therapeutic advances in IgAN.

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.