FDA News

The approval makes etuvetidigene autotemcel (Waskyra) the first cell-based gene therapy for the treatment of Wiskott-Aldrich syndrome.

Teva submitted an NDA on olanzapine extended-release injectable suspension (TEV-‘749) for adult schizophrenia to the FDA.

The approval of Ayrmid’s omidubicel-onlv makes it the first hematopoietic stem cell transplant therapy to treat patients with severe aplastic anemia.

This FDA News Month in Review provides a round-up of regulatory decisions from November 2025.

The accelerated approval expands Avance use to motor, mixed, and long-gap sensory nerve injuries, with required confirmatory trials to verify clinical benefit.

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

Key FDA approvals, pivotal IgAN and glomerular trial results, and transplant and CKD insights from November 2025.

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.