6 FDA Headlines You Missed in February 2026

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

February 2026 brought another active month of regulatory action from the Agency, with a mix of new approvals, expanded indications, and complete response letters across several therapeutic areas. From rare diseases to pediatric endocrinology and allergy care, the FDA’s February decisions reflected both continued progress in expanding treatment options and the challenges that remain in bringing new therapies to market.

Among the notable approvals were several aimed at addressing unmet needs in pediatric and rare disease populations. The FDA approved dupilumab for allergic fungal rhinosinusitis in patients aged ≥6 years with prior sinonasal surgery, marking the first therapy specifically indicated for this condition. The agency also approved ET-600 desmopressin acetate for pediatric central diabetes insipidus, expanded pediatric indications for the once-weekly growth hormone somapacitan-beco, and granted accelerated approval to navepegritide to increase linear growth in children with achondroplasia.

At the same time, the FDA issued Complete Response Letters (CRLs) for several investigational therapies, including Aquestive Therapeutics’ dibutepinephrine sublingual film for type 1 allergic reactions and Disc Medicine’s bitopertin for erythropoietic protoporphyria. Here’s a concise overview of the key FDA decisions and updates from February 2026.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

1. FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions

Announced by parent company Aquestive Therapeutics on February 2, 2026, the FDA issued a CRL to the Company’s NDA for dibutepinephrine (Anaphylm) Sublingual Film for the treatment of Type I allergic reactions, including anaphylaxis, in patients weighing ≥ 30kg (approximately 66 pounds). Issued on January 30, 2026, the CRL detailed deficiencies in the dibutepinephrine human factors validation study, including instances of difficulty opening the pouch and incorrect film placement which, if unaddressed, the FDA believes could cause significant safety issues in the setting of anaphylaxis.

Related: Anaphylm Remains Promising for Anaphylaxis Despite FDA CRL, With David Golden, MD

2. FDA Issues Complete Response Letter to Bitopertin For Erythropoietic Protoporphyria

On February 2, 2026, the FDA issued a CRL to Disc Medicine’s NDA for bitopertin as a treatment for patients with erythropoietic protoporphyria. In the CRL, the Agency acknowledged sufficient evidence of reduced whole blood metal-free protoporphyrin IX (PPIX) from the AURORA and BEACON trials but stated a need to see results of the ongoing phase 3 APOLLO study before bitopertin receives approval.

3. FDA Approves Dupilumab for AFRS in Patients Aged ≥ 6 Years With Prior Surgery

On February 24, 2026, the FDA approved dupilumab (Dupixent) for the treatment of allergic fungal rhinosinusitis in adults and pediatric patients aged ≥ 6 years with a history of sinonasal surgery. The decision, announced by Sanofi and Regeneron, marks the first FDA-approved therapy specifically indicated for allergic fungal rhinosinusitis, a subtype of chronic rhinosinusitis characterized by type 2 inflammation and high postsurgical recurrence rates.

4. FDA Approves ET-600 Desmopressin Acetate (Desmoda) for Central Diabetes Insipidus

On February 25, 2026, the FDA approved Eton Pharmaceuticals’ ET-600 to treat central diabetes insipidus among pediatric patients. ET-600, now under the label Desmoda, is the first and only FDA-approved oral liquid formulation of desmopressin. It will be supplied as a ready-to-use oral solution of 0.05 mg/mL that does not require tablet splitting, crushing, refrigeration, mixing, or shaking.

5. FDA Approves 3 New Pediatric Indications for Once-Weekly Somapacitan-beco (Sogroya)

On February 27, 2026, the FDA approved 3 new indications for Novo Nordisk’s once-weekly somapacitan-beco (Sogroya) injection 5 mg, 10 mg, or 15 mg. With the decision, the long-acting growth hormone is now indicated for children ≥ 2.5 years of age with Idiopathic Short Stature, short stature born Small for Gestational Age and with no catch-up growth by 2 years of age, or growth failure associated with Noonan Syndrome.

6. FDA Grants Accelerated Approval to Navepegritide for Achondroplasia in Children Aged 2 Years and Older

On February 27, 2026, the FDA granted accelerated approval to Ascendis Pharma’s navepegritide (Yuviwel), a once-weekly C-type natriuretic peptide (CNP) analog, to increase linear growth in children ≥ 2 years of age with achondroplasia and open epiphyses. The decision was based on improvements in annualized growth velocity (AGV) from 3 phase 3 trials, with continued approval contingent on confirmatory evidence of clinical benefit.