Abigail Brooks, MA

The CONNECT trial found CGM improved A1C and time in range in adults with type 2 diabetes not on insulin.

A post-hoc analysis of the STEP UP trial found that semaglutide 7.2 mg and 2.4 mg were linked to eGFR increases in adults with obesity who did not have diabetes.

STEP UP T2D data suggest semaglutide 7.2 mg's superiority to the 2.4 mg dose and placebo for proposed BMI and waist-to-height ratio treatment targets.

An EHR-based machine learning model predicted 10-year type 2 diabetes risk with near-ideal calibration in over 3 million adult patients.

From hepatitis D's first FDA-approved therapy to advances in hepatitis B and PBC, May delivered major developments in hepatology.

ACCESS phase 2b data show aleniglipron 120 mg produced 11.3% placebo-adjusted weight loss at 36 weeks, with continued reductions in the OLE.

Catch up on GI regulatory actions and top headlines from DDW in this May month in review.

Phase 2 JASMINE data show nipocalimab achieved SRI-4 response rates of 53.5% vs 46.7% with placebo at week 24, with benefits sustained through week 52.

Pooled B-Well phase 3 data show bepirovirsen achieved a 19% functional cure rate in CHB vs 0% with standard of care alone.

Study 108 interim data show 68% of UC patients remained in clinical remission at week 144 after de-escalating from 50 mg to 25 mg obefazimod daily.

The approval indicates linaclotide for pediatric patients ≥ 2 years of age with functional constipation, expanding its previous use in patients ≥ 6 years of age.

The Liver Disease Panel represents the first comprehensive library of certified healthcare algorithms to support chronic liver disease management.

The FDA approved Abbreviated New Drug Applications from Lupin Pharmaceuticals for Famotidine Injection USP, 20 mg/2 mL (10 mg/mL), Single-Dose Vials.

After roughly 14 months leading the agency and recent reports of the Trump administration planning his removal, FDA Commissioner Marty Makary, MD, MPH, has resigned.

Mitapivat has been submitted to the FDA for accelerated approval in sickle cell disease after phase 3 results showed a hemoglobin benefit.

Catch up on updates in viral hepatitis treatment, advances in rare liver disease care, and more.

Catch up on new IBD drug trial data, regulatory actions, and updates in IBS in this April month in review.

The phase 3 FUZION trial found guselkumab achieved increased fistula remission rates than placebo in perianal fistulizing Crohn's disease.

Updated results from the NordICC trial build upon previous 10 year findings and shed further light on once-only colonoscopy as a primary screening modality.

JNJ-4804 phase 2b results showed higher week-48 remission rates in refractory ulcerative colitis and Crohn disease.

Phase 4 dupilumab data show improvements in esophageal distensibility and disease-related structural changes and inflammation in the esophagus in EoE.

Long-term LUCENT-3 data show mirikizumab sustained disease clearance in ulcerative colitis through 4 years of treatment.

Volixibat reduced cholestatic pruritus in phase 2b primary sclerosing cholangitis data, with diarrhea and liver test elevations reported.

IBS care is evolving with personalized, multimodal strategies, but gaps in access, education, and real-world outcomes continue to impact patients’ lives

The FDA has accepted bepirovirsen's NDA for Priority Review and granted Breakthrough Therapy designation, with a PDUFA date of October 26, 2026.

The FDA approved anifrolumab via a once-weekly subcutaneous autoinjector for moderate to severe SLE based on phase 3 TULIP-SC trial results.

AbbVie submitted an FDA application for risankizumab subcutaneous induction in Crohn's disease based on phase 3 AFFIRM data.

New real world data suggest GLP-1 RAs do not drive DKA or pancreatitis risk in adult patients with type 1 diabetes and may reduce hospital admissions.

RCTs show intermittent fasting and calorie restriction yield similar HbA1c and cardiometabolic outcomes in type 2 diabetes, with modest, nonsignificant weight differences.

Results from the 52-week open-label extension trial highlight strong safety and efficacy outcomes with lonapegsomatropin in adults with growth hormone deficiency.