
This updated approval builds on the success of Fibryga’s 2024 approval for AFD, which was based on positive data from the phase 3 FIBRES trial.

This updated approval builds on the success of Fibryga’s 2024 approval for AFD, which was based on positive data from the phase 3 FIBRES trial.

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 FDA grants priority review of Vera Therapeutics’s Biologics License Application for the B-cell modulating, atacicept, in IgAN.

Q4 2025 psychiatry highlights: FDA approvals, clearances, and submissions, plus new clinical data shaping personalized treatment in MDD, bipolar, and schizophrenia.

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

Kohli discusses the importance of the FDA’s recent label change and how clinicians can help reduce the continued prescription of ineffective medication.

The pulmonology year in review highlights FDA approvals and pivotal data readouts.

This study highlights the efficacy and safety of deucravacitinib 6 mg in psoriasis, with results stratified by body mass index and age in a Japanese patient cohort.

Retrospective data suggest serum creatinine trajectories might predict 28-day mortality in acute kidney injury on chronic kidney disease.

A study found no differences in depressive symptom reduction when nonresponders continued therapy, switched therapists, or changed both therapist and treatment approach.

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

Zeidan discusses the interim results from the ongoing phase 1/2 trial, highlighting bexmarilimab’s efficacy in combination with azacitidine SoC.

A cross-sectional study in CKD suggests patients undergoing hemodialysis have increased social frailty and depression compared to transplant recipients.

Two phase 3 trials met their primary and secondary endpoints in patients with moderate-to-severe plaque psoriasis on envudeucitinib.

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.

Alixorexton receives FDA Breakthrough Therapy Designation, promising significant advancements in treating narcolepsy type 1.

This quarterly recap highlights some of the most notable news and developments in the dermatology space from Q4 in 2025.

Q4 2025 brought key FDA approvals and phase 3 advances in HAE, peanut allergy, multi-allergen immunotherapy, and allergic fungal rhinosinusitis.

Catch up with major FDA decisions, critical conference news, and more.

Data from the ongoing phase 4 PETITE-T1D study, highlighting the substantially reduced progression to stage 3 T1D, headline the application.

The updated guideline offers recommendations for RBC transfusions and iron management, while continuing to prioritize patient-centered care.

Investigators observed disparities in race with persistent chemotherapy-induced alopecia among women with breast cancer.

The designation follows positive phase 2b data and FDA alignment on a phase 3 trial.

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

A qualitative descriptive study of pediatric kidney transplant recipients and caregivers highlights a need for standardized educational materials and treatment information.

The NDA is based on positive 52-week data from the phase 3 VERIFY clinical trial, which demonstrated rusfertide’s capacity to reduce phlebotomy dependency.

A study identified early symptom improvement and greater baseline depression severity as predictors of sustained antidepressant response to adjunctive cariprazine in MDD.

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

Reau and Brown discuss new data on SGLT2 inhibitors, albumin dosing, AKI risk, and emerging at-home tools for hepatic encephalopathy in cirrhosis.

New research in patients with end-stage kidney disease suggests an association between neighborhood advantage and access to transplants and waitlists.