FDA News

The submission follows positive results from the BaxHTN trial, which saw the investigational aldosterone synthase inhibitor improve systolic BP versus placebo.

Biofrontera announced its submission of a supplemental New Drug Application to the FDA for Ameluz-PDT in superficial basal cell carcinoma (sBCC).

The acceptance comes on the heels of positive topline results comparing the new device to the current on-body infusor.

FDA grants accelerated approval for sibeprenlimab for reducing proteinuria in IgA nephropathy.

The FDA has approved RNA interference therapeutic plozasiran for the treatment of familial chylomicronemia syndrome.

The FDA acceptance of Arcutis's supplemental New Drug Application (sNDA) was announced for roflumilast cream 0.3% (Zoryve).

The FDA adds a boxed warning to delandistrogene moxeparvovec-rokl (ELEVIDYS) restricting indications to ambulatory patients with DMD.

FDA clears BrainsWay's Deep TMS for adolescents aged 15-21 years with major depressive disorder (MDD), expanding its use.

Julie Khlevner, MD, AGAF, highlights that FDA approval of linaclotide provides the first pharmacologic therapy for pediatric IBS-C.

At NASPGHAN 2025, investigators presented 52-week safety data from an ongoing phase 3 trial of linaclotide, the first approved treatment for patients aged 7 and older with IBS-C.

The decision makes linaclotide (Linzess) capsules the first FDA-approved treatment for pediatric patients 7 years and older with irritable bowel syndrome with constipation.

Catch up on the groundbreaking FDA approvals, key trial updates, and more news from the last month.

ABBV-CLS-628, an anti–PAPP-A monoclonal antibody, earns Orphan Drug Designation, advancing through phase 2 testing for ADPKD.

Stay up to date with the groundbreaking FDA decisions, critical trial updates, and more news from the last month.

Based on results from the THRIVE and THRIVE-2 phase 3 studies, this Biologics License Application includes a request for Priority Review.

Catch up with groundbreaking FDA decisions, exciting new GLP-1 news, and more.

The FDA has approved Kygevvi (doxycitine and doxribtimine), the first therapy to improve functional outcomes and survival in thymidine kinase 2 deficiency.

Following a Type A meeting with the FDA, the ophthalmic formulation of bevacizumab is back on track towards a potential US approval.

FDA approves Omvoh (mirikizumab-mrkz) for monthly maintenance of ulcerative colitis, simplifying treatment for patients with this chronic condition.

The phase 3 ZENITH trial showed sotatercept’s superiority over placebo in reducing morbidity and mortality outcomes in adults with WHO FC III or IV PAH.

FDA launches the Commissioner’s National Priority Voucher program, expediting drug reviews for critical health needs.

This approval represents an alternative method for approaching this undertreated disease, shortening recovery while minimizing invasiveness.

Rybelsus marks the first oral GLP-1 for major adverse cardiovascular events in adult patients with T2D, opening a new cardiovascular treatment pathway.

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.