FDA News

The FDA identified no issues with the safety or efficacy of aflibercept 8 mg in any of its already approved dosing regimens or indications.

Dupilumab's approval marks the first new, targeted therapy for CSU in more than a decade and is the 7th indication for a disease with underlying type 2 inflammation.

Label updates simplify twice-yearly echo monitoring for eligible patients in the maintenance phase and expand eligibility with reduced contraindications.

If approved, aflibercept 8 mg would mark the first RVO treatment indicated for up to every 8-week dosing, halving the injection frequency of other anti-VEGF options.

The FDA cleared the expanded indication for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome.

The interchangeable designation was granted to CT-P17, a biosimilar to adalimumab (Humira), for inflammatory diseases such as psoriasis.

A first-of-its-kind medication developed by Atsena Therapeutics, ATSN-201 has already received three other FDA designations.

The new tablet formulation of maralixibat for the treatment of cholestatic pruritus in patients with ALGS and PFIC is expected to be available in June.

VERVE-102 is targeting the reduction of LDL-C levels among individuals with hyperlipidemia and high lifetime cardiovascular risk.

With regulatory clearance for people aged ≥18 years with diabetes, Dexcom G7 boasts the longest-lasting wearable and most accurate CGM system.

Assigned a PDUFA target date of August 27, 2025, the resubmitted application for the wet AMD treatment will offer another chance for US approval.

BRIMOCHOL PF, a combination eye drop for presbyopia, achieved all primary and secondary endpoints in its most recent trial.

Aldeyra announces intention to resubmit NDA with new trial data in mid-year 2025.

The approval indicates Novartis's atrasentan (Vanrafia) for proteinuria reduction in primary IgA nephropathy.

The FDA granted fast-track status to Biogen’s BIIB080, a tau-targeting therapy for Alzheimer Disease, which is now being evaluated in the global phase 2 CELIA study.

March highlights groundbreaking advancements in ophthalmology, including FDA approvals for innovative treatments and alarming findings on pediatric eye health post-COVID.

The first quarter of 2025 saw approvals in diabetes, depression, kidney disease, and pain, among others. Read more about high-impact approvals of Q1 now.

The FDA accepted an sNDA for pegcetacoplan for C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis.

Ragni discussed unique advantages fitusiran offers over other approved therapies for hemophilia A or B.

The Biologics License Application submission for sibeprenlimab is supported by results from the phase 2 ENVISION and phase 3 VISIONARY clinical trials.

An audio recap of the top 5 stories in healthcare news from the week of 03/23-03/2.

Data from the phase 3 ATLAS trial supported Qfitlia's BLA, with the latest data presented at December’s ASH meeting.

Treprostinil (YUTREPIA) was previously granted tentative approval on August 16, 2024.

Announced on March 28, 2025, the FDA's CRL to Milestone Pharmaceuticals cites CMC issues, but no issues with safety or efficacy data.

The FDA approval of diazoxide choline extended-release tablets (Vykat XR) was announced on March 26, 2025.