Abigail Brooks, MA

The FDA approved a 12-hour OTC combination of guaifenesin, dextromethorphan, and naproxen for cold and influenza symptom relief.

The approval makes MannKind Corporation’s furosemide injection the first and only autoinjector delivering SC furosemide with IV-equivalent exposure.

Plozasiran cut triglycerides up to 81% and reduced acute pancreatitis events in phase 3 SHASTA-3, SHASTA-4 trials for severe hypertriglyceridemia.

Newly published phase 2b RELIEVE UCCD data show strong 14-week results for duvakitug in ulcerative colitis and Crohn disease.

Freenome reported updated SimpleScreen CRC results showing 80.4% colorectal cancer sensitivity and 90% specificity.

Catch up on Q2 hepatology headlines, including the historic FDA approval of bulevirtide for hepatitis delta, new data on bepirovirsen for HBV, and more.

Catch up on Q2 GI headlines you may have missed, including an expanded FDA approval for linaclotide, a submission for risankizumab SC induction in Crohn’s, and more.

Catch up on the latest in hepatology, from bulevirtide’s FDA approval for hepatitis delta to expert perspectives on new and emerging therapies in PBC, PSC, and MASLD.

Catch up on phase 3 data for tulisokibart and obefazimod, expert perspective on linaclotide's expanded FDA approval, and more.

A review of 22 novel drugs approved by the US Food and Drug Administration during the first half of 2026, with links to coverage from MJH Life Sciences publications.

Preview the biggest anticipated FDA decisions of Q3 2026, including atacicept for IgAN, mRNA flu vaccine, Furoscix ReadyFlow, and more.

Elecoglipron 75 mg produced 10.5% body weight reduction at 26 weeks in VISTA and a 1.9% HbA1c reduction at 26 weeks in SOLSTICE.

twiist improved time in range by 16 percentage points and reduced HbA1c by 0.7 points over 13 weeks in insulin-treated adults with type 2 diabetes, with no severe hypoglycemia events.

In the phase 2 SLIMMER-UP-SWITCH trial, ecnoglutide delivered greater weight loss and waist circumference reduction than semaglutide at 20 weeks in adults with obesity in China.

DKA remains a growing challenge in diabetes care, with new data highlighting missed diagnoses, rising admissions, and higher costs.

Across a trio of phase 3 trials, CagriSema delivered superior HbA1c reduction and weight loss versus semaglutide in adults with type 2 diabetes

Orforglipron added to titrated insulin glargine reduced HbA1c by up to 2.05% and body weight by up to 6.1% versus placebo, without increasing hypoglycemia risk.

In a post-hoc analysis of ATTAIN-1 and ATTAIN-2, the highest dose of orforglipron delivered meaningful weight loss across all menopause stages.

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.