News|Articles|July 1, 2026

8 FDA Headlines You Missed in June 2026

Author(s)Victoria Johnson

Fact checked by: Abigail Brooks, MA

This FDA News Month in Review provides a round-up of regulatory decisions from June 2026.

Welcome back to our recap of this month's news and updates from the US Food and Drug Administration (FDA)!

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Image Credit: US Food and Drug Administration

September 30th, 2026

FDA Approves Mavacamten for Pediatric Patients With Obstructive HCM

FDA approved mavacamten for oHCM in children weighing 30 kg or more after SCOUT-HCM showed a 48.0-mm Hg Valsalva LVOT gradient reduction vs placebo.

Donald Cutlip, MD | Image Credit: BAIM Institute for Clinical Research

September 28th, 2026

Q&A: Cutlip on the SELUTION SLR DEB’s FDA Approval for Coronary In-Stent Restenosis

Donald Cutlip, MD, discusses the sirolimus balloon’s approval and its role in clinical practice for patients with ISR.

September 25th, 2026

FDA Approves Baricitinib for Adolescents With Severe Alopecia Areata

Approval is based on 36-week data from BRAVE-AA-PEDS, in which 42% of patients on the 4 mg dose achieved a SALT score of 20 or less, compared with 5% on placebo.

September 25th, 2026

Zilurgisertib Receives FDA Approval for FOP in Patients 12 and Older

The FDA approved once-daily oral zilurgisertib for FOP in patients aged 12 years and older after the phase 2 PROGRESS trial showed reduced new heterotopic ossification vs placebo.