Abigail Brooks, MA

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.

Propensity-matched data link empagliflozin to lower risk of CV events, AKI, and other outcomes versus dapagliflozin in type 2 diabetes.

If approved, the novel corticosteroid therapy would be the first and only FDA-approved hydrocortisone acetate suppository.

View slated expert interviews and 7 clinical trials to watch at AACE Annual Meeting 2026.

Experts discuss diagnostic challenges, variable presentations, and strategies to improve outcomes in Wilson disease.

Clinicians discuss diagnostic gaps, treatment strategies, and multidisciplinary care in Wilson disease.

Positive 12-week induction data from Part A of the phase 2 trial highlight the potential best-in-class safety and efficacy of SPY001, a novel anti-α4β7 therapy.

March 2026 endocrinology updates include key FDA approvals, advances in diabetes and obesity therapies, and innovations in insulin delivery and rare disease care.

March 2026 cardiology updates feature key ACC.26 data, new guidelines, and advances in PAH, AF, hypertension, and lipid management.

Q1 2026 GI updates include advances in IBD and IBS therapies, long-term data, and new insights into access challenges for younger patients.

Q1 2026 hepatology highlights include advances in MASH, hepatitis B, gene editing for AATD, and the first approved therapy for pruritus in PBC.

Key hepatology updates from March 2026, including a first-in-class PBC therapy, viral hepatitis insights, and emerging research in MASLD and HCC.

Catch up on new IBD drug trial data, updated HE guidelines from the American College of Gastroenterology, and more.