Abigail Brooks, MA

Data presented at the World Congress of Nephrology highlight faster and higher rates of microscopic hematuria negativity with sibeprenlimab treatment.

The Agency approved Lilly’s orforglipron (Foundayo) for adults with obesity or overweight. It can be taken any time of the day without restrictions on food and water intake.

The IBAT inhibitor’s approval, the first for this indication, was based on data from the GLISTEN trial showing reductions in cholestatic pruritus and itch-related sleep interference.

The approval is based on results from the STEP UP trial program showing substantial weight loss in adults with obesity.

The first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist delivered superior A1C reduction and weight loss at 40 weeks in people with type 2 diabetes.

The MiniMed Flex is a discreet, smartphone-controlled insulin pump that is roughly the size of 2 stacked insulin vials.

New data show tegoprubart enabled insulin independence and strong glycemic control in adults with long-standing type 1 diabetes undergoing islet transplantation.

New CKD therapies and a cardiometabolic care model are reshaping kidney disease management.

Experts discuss gaps in CKD detection, the role of albuminuria testing, and the need for earlier, risk-based care to improve outcomes.

The approval comes after the FDA requested GSK submit an sNDA for leucovorin for the treatment of CFD-FOLR1.

The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat in hypertension, but the selective aldosterone synthase inhibitor fell short in a phase 2 obstructive sleep apnea trial.

The FDA approval of milsaperidone and a pair of positive trials in depression signal a month of progress in psychiatry.

This FDA News Month in Review provides a round-up of regulatory decisions from February 2026.

Catch up on durability data and real-world insight from trials across inflammatory bowel disease and short bowel syndrome.

Catch up on new trial readouts, trends in hepatitis B birth dose vaccination, updates in a rare hepatic disease in honor of Rare Disease Day, and more.

Risankizumab achieved superiority for the co-primary and ranked secondary endpoints at week 12 for SC injection versus placebo.

The long-acting growth hormone is now indicated for children aged 2.5 years and older with Idiopathic Short Stature, born Small for Gestational Age, or Noonan Syndrome.

Ross Milner, MD, discusses rising vascular complexity, advanced imaging and AI, and the team-based strategies driving durable aortic and limb salvage outcomes.

Manreet Kanwar, MD, outlines advances in heart failure care, rising medication complexity, and the need for integrated, patient-centered systems.

David Rubin, MD, discusses rapid advances in IBD care, new therapies, multidisciplinary models, and the push toward precision GI medicine.

In a phase 2 trial in Chinese people with overweight or obesity, UBT251 led to mean weight loss of up to 19.7% (-17.5 kg) after 24 weeks.

The FDA has granted both designations to TSRA-196, an in vivo gene editing program from Tessera Therapeutics, for the treatment of PiZZ alpha-1 antitrypsin deficiency.

Positive results from a follow-up preclinical study of Thykamine show dose-dependent effects on key pathological hallmarks of MASH.

Interim data from the investigator-initiated trial showed treatment with a single dose of YOLT-202 led to rapid, dose-dependent increases in AAT levels to normal range.

Experts discuss shifting CKD detection upstream, improving albuminuria screening, and enabling earlier, risk-based intervention.

Survey findings highlight abdominal and bowel symptom control, affordability, and formulary or insurance coverage as factors driving perceptions and prescribing patterns of PERT.

The data represent the highest and most significant improvement in AHV and the first statistically significant improvement in body proportionality in achondroplasia.

Positive topline data from Hengrui’s phase 2 clinical trial of once-daily oral ribupatide highlight weight loss of up to 12.1% with no observed plateau at 26 weeks.

Catch up on hepatic FDA news, expert insights on PBC and MASH developments, & more.

Catch up on disparities in IBD care, a potential new IBS drug, new insight on diet’s role in Crohn’s disease care, & more.