FDA News

Tezepelumab is the first TSLP-targeting biologic to be approved for chronic rhinosinusitis with nasal poylps.

The FDA approved expanded indications for adalimumab-aaty (Yuflyma) and its unbranded version to include the treatment of adolescent HS and pediatric UV.

Santreva-ATK, the first wire-free endovascular revascularization catheter for crossing chronic total occlusions, is expected to begin sale in October 2025.

The therapy is currently approved in almost 50 countries under the name Trimbow.

Maher discussed the new FDA approved drug, marketed as Jascayd, and its impact for idiopathic pulmonary fibrosis.

The decision updates the indication statements for ulcerative colitis and Crohn’s disease to allow use in patients who have received ≥ 1 approved systemic therapy.

The sBLA for insulin human Inhalation Powder in children and adolescents with type 1 or type 2 diabetes was assigned a PDUFA target action date of May 29, 2026.

FDA approves UZEDY, a long-acting risperidone injection, for adults with bipolar I disorder.

The Q3 recap for ophthalmology spotlights major FDA decisions and major clinical trial updates in a variety of diseases.

The Q3 recap for endocrinology spotlights major FDA decisions, new guidelines for managing diabetes during pregnancy, and major clinical trial updates.

The new therapy, marketed as Jascayd, previously demonstrated safety and efficacy in the phase 3 FIBRONEER-IPF trial.

The Q3 recap for cardiology spotlights major FDA decisions, new heart failure and hypertension guidelines, and top trial results and research.

Catch up on FDA decisions, critical trial results, and expert perspectives on endocrinology.

Read about groundbreaking FDA decisions, exciting new heart failure research, and more.

The approval is supported by data from the INTEGUMENT-PED phase 3 trial, the INTEGUMENT-OLE long-term extension study, and a phase 1 pharmacokinetic study.

Explore key FDA decisions in Q4 2025, impacting treatments for atopic dermatitis, chronic rhinosinusitis, and rare diseases.

The first oral BTK inhibitor for CSU offers fast relief for patients uncontrolled on antihistamines and an alternative to injectable biologics.

The FDA has approved remibrutinib, a new oral treatment for chronic spontaneous urticaria, offering hope for patients unresponsive to antihistamines.

Denecimig may offer a prophylaxis bleed treatment option for a range of patients across dosing frequencies, age groups, and condition severity.

The resubmission is based on results from 5 randomized clinical trials in the ONWARDS type 2 diabetes phase 3a program.

The approval of the selectively targeted somatostatin receptor type 2 agonist is supported by data from the phase 3 PATHFNDR-1 and PATHFNDR-2 trials.

The extended indication includes children 1 to < 5 years of age with homozygous familial hypercholesterolemia.

Biolinq Shine aims to provide continuous glucose monitoring, as well as sleep and activity data, without requiring injections.

The Agency initiated an acetaminophen label change to reflect evidence of potential harms in pregnant women and an approval of leucovorin for CFD.

The approval offers the flexibility of self-administration from the start of treatment for UC, building on the prior approval of SC induction in Crohn’s disease.