Abigail Brooks, MA

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.

Study findings highlight the importance of etiology-based chronic pancreatitis management, with NARCP linked to worse mortality, EPI, and other clinical outcomes.

The investigational antisense oligonucleotide met the primary endpoint for functional cure rate in the phase 3 B-Well 1 and B-Well 2 trials in chronic hepatitis B.

The Q4 recap for hepatology spotlights new AASLD guidelines, changes to CDC hepatitis B vaccination recommendations, and more.

Catch up on IBD steroid exposure risk, intensive weight loss before colorectal cancer surgery, a new chronic idiopathic constipation treatment option, and more.

Crohn’s & Colitis Foundation survey findings show 18% of young adults with IBD work extra hours to afford care and > 1 in 3 are not confident navigating insurance.

The decision expands upon caplacizumab’s 2019 approval for adults with acquired thrombotic thrombocytopenic purpura.

Catch up on new infant hepatitis B vaccine recommendations, liver transplant guidelines, research on GLP-1 RAs, and more.

The 2025 cholangitis year in review covers PBC and PSC advances, FDA designations, trial data, and evolving treatment pathways.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

The hepatology year in review highlights FDA approvals, MASH therapies, viral hepatitis advances, cholestatic disease shifts, and evolving clinical guidance.

The approval indicates narsoplimab as the first and only treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy.

The hepatitis year in review covers FDA approvals, HBV and HDV breakthroughs, HCV label expansion, clinical guidelines, and vaccine policy changes.

The MASH/MASLD year in review highlights FDA approvals, resmetirom data, semaglutide, pemvidutide, and advances in fibrosis and noninvasive endpoints in 2025.

The approval is based on the 64-week phase 3 OASIS 4 trial showing an average weight loss of ~17% if all patients stayed on treatment with semaglutide and ~14% regardless of if patients stayed on treatment.

The approval is based on phase 3 SEQUOIA-HCM clinical trial. The full US Prescribing Information includes a Boxed Warning for the risk of heart failure.

The decision makes nerandomilast the first and only PDE4B inhibitor with immunomodulatory and antifibrotic effects approved in this indication.

Positive topline results from the phase 2b IMPACT trial show statistically significant improvements in key noninvasive tests with pemvidutide.

Grifols’ fibrinogen concentrate is now approved for acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency.

The highly selective oral TYK2 inhibitor met coprimary endpoints for sPGA 0/1 and PASI 75 at week 16 versus placebo in the phase 3 Latitude studies.