Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
News|Articles|December 5, 2025
5 FDA Headlines You Missed in November 2025
Author(s)Victoria Johnson
Fact checked by: Abigail Brooks, MA
This FDA News Month in Review provides a round-up of regulatory decisions from November 2025.
Advertisement
Advertisement
Welcome back to our recap of this month's news and updates from the
Related to this article
FDA novel drug approvals in Q3 2026: 22 new therapies, including enlicitide, daraxonrasib, oveporexton, and first treatments for rare diseases.
Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
In a phase 3 study, telikibart achieved EASI-75 in 69.6% of adult patients with atopic dermatitis at Week 16, with rates above 94% by Week 52.
An indirect comparison finds higher placebo-adjusted skin and itch responses with upadacitinib vs nemolizumab in atopic dermatitis.
The FDA set a June 18, 2027, PDUFA date for the subcutaneous GP IIb/IIIa inhibitor, based on phase 3 CeleBrate data.
Stay up-to-date with the latest FDA approvals, trial readouts, and key clinician insights across cardiovascular care.
Patients with obesity or overweight and T2D saw substantially greater mean weight loss and HbA1c improvement with petrelintide versus placebo.
Advertisement
Advertisement