Abigail Brooks, MA

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.

The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.

The US Centers for Medicare & Medicaid Services selected 15 high-cost drugs for the third cycle of the Medicare Drug Price Negotiation Program, including the first-ever Part B drugs.

With the acceptance, the FDA has assigned the oral phosphate binder a Prescription Drug User Fee Act target action date of June 29, 2026.

An FDA review found no increased risk of SI/B associated with the use of GLP-1 RA medications, including liraglutide, semaglutide, and tirzepatide.

Open-label RCT findings suggest a short-term, calorie-restrictive diet may be an effective intervention for mild and moderate Crohn’s disease.

The NDA is supported by data from the phase 3 TRIUMpH clinical program and seeks approval for heartburn in NERD, healing of erosive esophagitis, and maintenance of healing.

Topline 52 week results show durable growth without compromising safety or tolerability, as well as benefits beyond linear growth with combination treatment.

The document outlines 14 best-practice advice statements for diagnosing and managing refractory constipation, with an emphasis on surgical intervention.

A trio of professional societies voice concerns about certain elements of the Dietary Guidelines for Americans, 2025–2030, and their potential negative health impacts.

Clinically meaningful improvements in global IBS symptom severity were observed as early as week 1 and sustained through week 7.

The Q4 recap for gastroenterology spotlights GI FDA news, new AGA guidelines, trial data for UC therapies, and more.