FDA News Recap: Novel Drug Approvals in Q2 2026

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

Q2 2026 delivered one of the most active regulatory quarters in recent memory, spanning novel first-in-class approvals, landmark pediatric expansions, and several long-anticipated decisions across endocrinology, nephrology, dermatology, ophthalmology, and rheumatology. The quarter's standout approval came on April 1, when orforglipron became the first once-daily oral small-molecule GLP-1 receptor agonist approved for adults with obesity or overweight — a class-first that requires no food or water restrictions. In nephrology, sparsentan received the first-ever FDA approval for focal segmental glomerulosclerosis in April, offering the only non-immunosuppressive oral option for a disease with no previously approved therapy.

June rounded out the quarter with the accelerated approval of teplizumab as the first disease-modifying therapy for children aged 8 to 17 recently diagnosed with stage 3 type 1 diabetes, the approval of olezarsen as the first agent specifically indicated to reduce acute pancreatitis risk in severe hypertriglyceridemia, and veligrotug-vvze as the first thyroid eye disease therapy approved with labeling covering both active and chronic disease. Additional highlights include dupilumab's expansion to children aged 2 to 11 with chronic spontaneous urticaria, risankizumab's first-ever pediatric approval for plaque psoriasis and psoriatic arthritis, the subcutaneous anifrolumab autoinjector for systemic lupus erythematosus, and bemotrizinol's addition to the OTC sunscreen monograph as the first new active ingredient in more than 25 years.

Here's a concise overview of the key FDA decisions and updates from Q2 2026:

1. Orforglipron (Foundayo)

Date: April 1, 2026

Indication: Adults with obesity, or adults with overweight who also have at least 1 weight-related medical problem, as an adjunct to reduced-calorie diet and increased physical activity

Background: Orforglipron (Foundayo; Eli Lilly) is a once-daily small-molecule non-peptide oral GLP-1 receptor agonist — the first in the GLP-1 class that can be taken at any time without food or water restrictions. In the phase 3 ATTAIN-1 trial (n = 3127 adults without diabetes), participants on the highest dose lost an average of 27.3 pounds (12.4%) at 72 weeks vs 2.2 pounds (0.9%) with placebo, with improvements across cardiometabolic risk markers including waist circumference, non-HDL cholesterol, and systolic blood pressure. The small-molecule formulation bypasses the timing constraints associated with existing oral peptide-based GLP-1 therapies, a distinction with potential implications for adherence. A regulatory submission for a type 2 diabetes indication is anticipated later in 2026.

Related coverage: Diabetes Dialogue: Orforglipron Receives FDA Approval for Chronic Weight Management

2. Sparsentan (Filspari)

Date: April 13, 2026

Indication: Focal segmental glomerulosclerosis (FSGS) in adults and children aged 8 years and older

Background: Sparsentan (Filspari; Travere Therapeutics) is the first-ever FDA-approved therapy for FSGS, a leading cause of nephrotic syndrome and primary FSGS-related kidney failure that had no approved pharmacotherapy prior to this action. The drug is the only non-immunosuppressive oral agent indicated for the condition; it directly targets podocyte injury by blocking both endothelin A receptors and angiotensin II subtype 1 receptors, reducing proteinuria beyond what is achievable with maximal renin-angiotensin system blockade alone. The approval was supported by the phase 3 DUPLEX trial and phase 2 DUET study. The PDUFA date had been extended from January 13 to April 13, 2026, following an FDA request for further characterization of clinical benefit. Sparsentan had previously received full FDA approval for IgA nephropathy.

Related coverage: Why Sparsentan's FDA Approval Marks a Turning Point in FSGS, With Howard Trachtman, MD

3. Dupilumab (Dupixent)

Date: April 22, 2026

Indication: Chronic spontaneous urticaria (CSU) in children aged 2 to 11 years that remains symptomatic despite H1 antihistamine treatment

Background: The FDA's approval of dupilumab (Dupixent; Regeneron/Sanofi) for CSU in children aged 2 to 11 extends the prior indication in adults and adolescents aged 12 and older, making it the first biologic approved for CSU in this younger age group. Dupilumab is an IL-4Rα inhibitor that blocks both IL-4 and IL-13 signaling; its upstream mechanism of action may address the type 2 inflammatory drivers that contribute to mast cell activation in antihistamine-refractory CSU. The expansion addresses a population in whom antihistamine failure leaves limited therapeutic options and disease burden can substantially affect quality of life and development.

4. Anifrolumab-fnia (Saphnelo Pen)

Date: April 27, 2026

Indication: Subcutaneous self-administration in adults with moderate to severe systemic lupus erythematosus (SLE) receiving standard therapy

Background: The FDA approved a subcutaneous once-weekly 120 mg autoinjector formulation of anifrolumab-fnia (Saphnelo Pen; AstraZeneca), a type I interferon receptor antagonist, expanding on the existing intravenous infusion route and enabling patient self-administration outside the clinical infusion setting. Approval was based on the phase 3 TULIP-SC trial, in which 29% of patients achieved DORIS remission and 40.1% attained low-level disease activity. The subcutaneous formulation may improve long-term convenience and adherence in a chronic disease requiring sustained biologic management, and avoids the scheduling burden associated with regular infusion visits.

5. Bemotrizinol (PARSOL Shield)

Date: June 9, 2026

Indication: Addition to the OTC sunscreen monograph as an active sunscreen ingredient at concentrations up to 6%, for adults and children aged 6 months and older

Background: Bemotrizinol (PARSOL Shield; DSM-Firmenich) became the first new active sunscreen ingredient permitted in the US since the late 1990s, closing a more than 25-year gap during which available UV filters in American sunscreens lagged behind those available in Europe and Asia. The action was finalized in approximately 7 months under the CARES Act administrative order pathway, the first ingredient to clear this streamlined process. Bemotrizinol provides broad-spectrum UVA and UVB coverage with high photostability, low percutaneous absorption, and no white cast — addressing both efficacy and cosmetic tolerability limitations associated with some older organic filters. Manufacturers may begin incorporating it into OTC products beginning August 9, 2026, with DSM-Firmenich holding exclusive marketing rights for the first 18 months.

6. Teplizumab-mzwv (Tzield)

Date: June 12, 2026

Indication: To delay the decline of endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D)

Background: Teplizumab-mzwv (Tzield; Sanofi) received accelerated approval for this new indication, making it the first FDA-approved disease-modifying therapy for patients recently diagnosed with stage 3 T1D. The anti-CD3 monoclonal antibody partially exhausts the autoreactive T cells driving pancreatic beta-cell destruction; approval relies on C-peptide preservation as a surrogate endpoint from the phase 3 PROTECT trial, with continued authorization contingent on confirmatory data from the ongoing BETA-PRESERVE trial. Tzield had previously been approved to delay progression from stage 2 to stage 3 T1D; this action extends its disease-modifying role into the newly diagnosed clinical disease setting. The drug carries a boxed warning for serious viral reactivation, including Epstein-Barr virus and cytomegalovirus.

7. Olezarsen (Tryngolza)

Date: June 24, 2026

Indication: Adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (triglycerides ≥500 mg/dL)

Background: Olezarsen (Tryngolza; Ionis Pharmaceuticals) became the first therapy approved specifically to reduce acute pancreatitis risk in severe hypertriglyceridemia, addressing a gap that persisted despite decades of available triglyceride-lowering agents — none of which had generated sufficient pancreatitis event data in controlled trials to establish a risk reduction claim. The antisense oligonucleotide inhibits hepatic APOC3 production to enhance triglyceride clearance; phase 3 CORE and CORE2 data showed placebo-adjusted fasting triglyceride reductions of approximately 49% to 72% at 6 months and an 85% reduction in acute pancreatitis events. Approval arrived ahead of the June 30 PDUFA date and extends olezarsen's existing US label for familial chylomicronemia syndrome to the broader severe hypertriglyceridemia population, estimated at more than 3 million US adults.

8. Veligrotug-vvze (Lumvoa)

Date: June 26, 2026

Indication: Thyroid eye disease (TED), regardless of disease activity or duration

Background: 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, became the first TED therapy approved with labeling covering both active and chronic disease and the first in this class to demonstrate a statistically significant effect on both diplopia response rate and complete resolution of diplopia across the full disease spectrum. Approval was granted with Priority Review and Breakthrough Therapy designation, based on the phase 3 THRIVE and THRIVE-2 trials evaluating a 12-week IV regimen administered as 5 infusions every 3 weeks. Safety monitoring is warranted for hearing impairment (potentially permanent), hyperglycemia (~12%), and infusion reactions (~9%).

9. Risankizumab-rzaa (Skyrizi)

Date: June 26, 2026

Indication: Moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for systemic therapy or phototherapy; active psoriatic arthritis in children aged 6 years and older

Background: Risankizumab-rzaa (Skyrizi; AbbVie), an IL-23 inhibitor that selectively binds the p19 subunit to suppress the inflammatory cascade driving psoriatic disease, became the first IL-23 inhibitor approved in the US for pediatric patients weighing less than 40 kg with either condition. 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. The pediatric plaque psoriasis approval is supported by the phase 3 OptIMMize program, which showed clinically meaningful sPGA and PASI improvements at week 16 sustained through week 52 in children aged 6 to 11; the psoriatic arthritis indication is supported by the OptIMMize psoriasis data plus population pharmacokinetic modeling from adult PsA trials. Risankizumab already holds adult approvals for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.