8 FDA Headlines You Missed in June 2026

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

June 2026 brought a busy regulatory calendar spanning endocrinology, dermatology, cardiology, nephrology, and ophthalmology, alongside 2 manufacturing-driven complete response letters. Highlights include the accelerated approval of teplizumab (Tzield; Sanofi) as the first disease-modifying therapy for children aged 8 to 17 recently diagnosed with stage 3 type 1 diabetes, and the approval of olezarsen (Tryngolza; Ionis Pharmaceuticals) as the first therapy specifically indicated to reduce acute pancreatitis risk in severe hypertriglyceridemia.

In dermatology, lebrikizumab (Ebglyss; Eli Lilly) gained an every-8-week maintenance dosing option for atopic dermatitis — the only biologic in its class approved at that frequency — and bemotrizinol (PARSOL Shield) became the first new OTC sunscreen ingredient approved in the US in more than 25 years. Risankizumab (Skyrizi; AbbVie) became the first IL-23 inhibitor approved for pediatric plaque psoriasis and psoriatic arthritis in children as young as 6, while veligrotug-vvze (Lumvoa; Viridian Therapeutics) received approval for thyroid eye disease regardless of activity or duration, the first TED therapy labeled for both active and chronic disease. On the CRL side, both cytisinicline and oxylanthanum carbonate were blocked again by third-party manufacturing deficiencies, with no clinical concerns raised in either action.

Here's an overview of the key FDA decisions and updates from June 2026:

FDA Issues CRL for Cytisinicline NDA in Smoking Cessation

Cytisinicline (Achieve Life Sciences), a plant-derived partial agonist at the α4β2 nicotinic acetylcholine receptor submitted as a smoking cessation pharmacotherapy, received a Complete Response Letter on its June 20, 2026, PDUFA date, with the FDA citing manufacturing-related observations from an inspection of a third-party facility and incomplete final product labeling rather than clinical deficiencies. The NDA was supported by phase 3 ORCA-2 and ORCA-3 data demonstrating greater smoking abstinence with cytisinicline vs placebo through 24 weeks, alongside safety data from more than 1500 clinical trial participants. Achieve has since partnered with Adare Pharma Solutions as a new manufacturer and plans a fourth-quarter 2026 resubmission, with potential approval in the first half of 2027.

FDA Approves Veligrotug-vvze for Thyroid Eye Disease

Veligrotug-vvze (Lumvoa; Viridian Therapeutics), a monoclonal antibody that fully antagonizes the insulin-like growth factor-1 receptor (IGF-1R) to disrupt the IGF-1R/TSHR cross-talk driving orbital inflammation in thyroid eye disease (TED), received FDA approval on June 26, 2026, for the treatment of TED regardless of disease activity or duration. The approval — granted with Priority Review and Breakthrough Therapy designation based on the phase 3 THRIVE and THRIVE-2 trials — makes veligrotug the first TED therapy with labeling covering both active and chronic disease and the first in this class to demonstrate a statistically significant effect on both diplopia response and complete diplopia resolution across the full disease spectrum. Viridian has announced an immediate US launch with a patient support program.

FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis

Risankizumab (Skyrizi; AbbVie), an IL-23 inhibitor that selectively binds the p19 subunit to suppress the inflammatory cascade driving psoriatic disease, received FDA approval on June 26, 2026, for children aged 6 and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor approved in the US for pediatric patients weighing less than 40 kg. A new 55-mg prefilled syringe supports weight-based dosing for children under 40 kg, complementing the existing 150-mg formulation for those at or above that threshold. Approval was supported by the phase 3 OptIMMize program, which showed clinically meaningful sPGA and PASI improvements at week 16 sustained through week 52 in younger children.

FDA Issues CRL for Oxylanthanum Carbonate in Hyperphosphatemia for CKD Patients on Dialysis

Oxylanthanum carbonate (OLC; Unicycive Therapeutics), a next-generation lanthanum-based phosphate binder using proprietary nanoparticle technology, received a second Complete Response Letter on June 30, 2026, for the treatment of hyperphosphatemia in patients with CKD on dialysis — the same day as its PDUFA date for the NDA resubmission. As with the original June 2025 CRL, the agency cited unresolved deficiencies at a third-party manufacturing vendor and raised no concerns about clinical efficacy, safety, or the drug's chemistry, manufacturing, and controls data. Unicycive has identified a backup manufacturer that has already produced OLC drug product and plans to seek a Type A meeting with the FDA to determine the path to resubmission.

FDA Approves Olezarsen (Tryngolza) for Severe Hypertriglyceridemia

Olezarsen (Tryngolza; Ionis Pharmaceuticals), an antisense oligonucleotide that reduces apolipoprotein C-III (APOC3) production in the liver to enhance triglyceride clearance, received FDA approval on June 24, 2026 — ahead of its June 30 PDUFA date — for severe hypertriglyceridemia (triglycerides ≥500 mg/dL), becoming the first therapy specifically indicated to reduce the risk of acute pancreatitis in this population. The CORE and CORE2 trials demonstrated placebo-adjusted fasting triglyceride reductions of approximately 49% to 72% at 6 months sustained through 12 months, alongside an 85% reduction in acute pancreatitis events vs placebo. The approval extends olezarsen's existing US label for familial chylomicronemia syndrome to the broader sHTG population, estimated at more than 3 million US adults.

Teplizumab Receives Accelerated FDA Approval for Stage 3 T1D in Children

Teplizumab (Tzield; Sanofi), an anti-CD3 monoclonal antibody that partially exhausts the autoreactive T cells driving pancreatic beta-cell destruction in type 1 diabetes, received accelerated FDA approval on June 12, 2026, for a new indication: delaying the decline in endogenous insulin production in children and adolescents aged 8 to 17 years recently diagnosed with stage 3 T1D, making it the first disease-modifying therapy approved for this population. Approval relies on C-peptide preservation as a surrogate endpoint from the phase 3 PROTECT trial, with continued authorization contingent on confirmatory data; teplizumab carries a boxed warning for serious viral reactivation, including Epstein-Barr virus and cytomegalovirus. The indication expands teplizumab's existing label, which covers delay of stage 3 T1D progression in patients aged 1 year and older with stage 2 disease.

FDA Adds Bemotrizinol: First New Sunscreen Ingredient in Decades

Bemotrizinol (PARSOL Shield; DSM-Firmenich), a broad-spectrum oil-soluble UV filter with high photostability and low percutaneous absorption that has been used in European sunscreens since 2000, was added to the FDA's OTC sunscreen monograph on June 9, 2026, as the first new US-approved sunscreen active ingredient since the late 1990s. The action, finalized in approximately 7 months under the CARES Act administrative order pathway, permits its use at concentrations up to 6% in products for adults and children aged 6 months and older; manufacturers may begin incorporating it into OTC products beginning August 9, 2026, with DSM-Firmenich holding exclusive marketing rights for the first 18 months. Bemotrizinol is notable for providing both UVA and UVB protection without leaving a white cast, addressing both efficacy and cosmetic tolerability limitations associated with some older organic filters.

FDA Approves Lebrikizumab Every-8-Week Maintenance Dosing for Atopic Dermatitis

Lebrikizumab (Ebglyss; Eli Lilly), an IL-13 inhibitor for moderate-to-severe atopic dermatitis in adults and adolescents aged 12 and older weighing at least 40 kg, received FDA approval on June 9, 2026, for a once-every-8-week maintenance dosing regimen — allowing eligible patients to receive as few as 6 injections per year without a mandatory concomitant topical therapy, and making it the only biologic in this class approved at that dosing frequency. The update is supported by exposure-response modeling and a 32-week open-label extension of the phase 3 ADjoin long-term trial in patients who had completed 100 weeks in the core program, with no new safety signals identified. Under the updated label, patients transition to every-8-week or every-4-week maintenance after an induction period of 250 mg every 2 weeks through week 16.