8 FDA Headlines You Missed in August 2025

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

In August 2025, the FDA issued a series of landmark decisions spanning neurology, pulmonology, rare diseases, pain, and metabolic health. Highlights included the first approval of a CGRP antagonist for pediatric migraine prevention with fremanezumab, new authorizations for PharmaTher’s ketamine in surgical pain and Tonix’s TNX-102 SL as the first fibromyalgia therapy in over 15 years, and the historic approval of brensocatib as the first disease-modifying treatment for bronchiectasis. Additional milestones featured the first immunotherapy for recurrent respiratory papillomatosis with zopapogene imadenovec, semaglutide’s expansion into metabolic dysfunction-associated steatohepatitis with fibrosis, and Ionis’ donidalorsen to prevent hereditary angioedema attacks. The month also closed with a setback, as Outlook Therapeutics received a Complete Response Letter for ONS-5010 in wet AMD, due to a trial's failure to meet its primary endpoint. Here’s a concise overview of the key FDA decisions and updates from August 2025.

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FDA News Month in Review: August 2025

1. FDA Approves Fremanezumab to Prevent Episodic Migraine in Children

On August 6, 2025, Teva Pharmaceuticals announced FDA approval of fremanezumab (AJOVY) for the preventive treatment of episodic migraine in children and adolescents aged 6–17 years weighing at least 99 pounds. Based on phase 3 SPACE trial results, the therapy significantly reduced monthly migraine and headache days versus placebo and demonstrated a consistent safety profile in pediatric patients compared with adults. This marks the first approval of a CGRP antagonist for pediatric episodic migraine prevention, expanding fremanezumab’s prior adult indication. The treatment is available as a once-monthly injection, with common adverse events including injection site reactions.

2. FDA Approves PharmaTher’s Ketamine for Surgical Pain Management

On August 8, 2025, PharmaTher announced FDA approval of ketamine (KetaRx) for surgical pain management. Based on resolution of prior complete response letters that required clarification of manufacturing and product details without new clinical trials, the approval provides an additional option amid ongoing ketamine shortages. The dissociative anesthetic, long included on the WHO Model List of Essential Medicines, is expected to support perioperative pain care while also laying groundwork for potential future indications in psychiatry, neurology, and chronic pain. PharmaTher noted the approval positions the company to expand its ketamine-based pharmaceutical portfolio globally.

3. FDA Approves First Bronchiectasis Therapy, Brensocatib, for Ages 12 and Up

On August 12, 2025, the FDA approved brensocatib (Brinsupri) 10 mg and 25 mg for adults and adolescents with non-cystic fibrosis bronchiectasis, marking the first disease-modifying therapy for this condition. The approval was supported by results from the phase 3 ASPEN trial, which demonstrated significant reductions in pulmonary exacerbation rates over 52 weeks compared with placebo. Nearly half of patients receiving brensocatib remained exacerbation-free at one year, and improvements in lung function were observed, particularly with the higher dose. Safety findings were generally consistent across groups, with hyperkeratosis noted more often in treated patients.

4. Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis

On August 14, 2025, the FDA approved zopapogene imadenovec-drba (Papzimeos) as the first non-replicating adenoviral vector-based immunotherapy for adults with recurrent respiratory papillomatosis (RRP). The decision, supported by pivotal phase 1/2 trial data showing a 51% complete response rate and durable reductions in surgical burden, represents a transformative step for a rare HPV-driven disease long managed primarily through repeated surgeries. With a favorable safety profile and meaningful clinical benefit, the therapy introduces a novel immunotherapy option that directly addresses the cycle of recurrence and morbidity in RRP.

5. FDA Approves TNX-102 SL, First New Fibromyalgia Therapy in 15 Years

On August 15, 2025, the FDA approved Tonix Pharmaceuticals’ TNX-102 SL (Tonmya) for the treatment of adults with fibromyalgia, marking the first new drug for the condition in more than 15 years. The sublingual cyclobenzaprine formulation, also the first in a new class of non-opioid analgesics for fibromyalgia, demonstrated significant reductions in daily pain scores and improvements in sleep, fatigue, and quality of life measures in the phase 3 RESILIENT trial. With a tolerable safety profile and rapid onset of effect, Tonmya introduces a novel therapeutic option for a patient population with historically limited treatment choices.

6. FDA Approves Semaglutide (Wegovy) Injection 2.4 mg for Noncirrhotic MASH

On August 15, 2025, the FDA approved Novo Nordisk’s semaglutide (Wegovy) 2.4 mg injection for adults with metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced fibrosis, making it the first GLP-1 receptor agonist authorized for this indication. The approval was supported by phase 3 ESSENCE trial results, in which semaglutide significantly improved liver histology, with 63% of patients achieving resolution of steatohepatitis without worsening fibrosis and 37% showing fibrosis improvement without worsening steatohepatitis at 72 weeks.

7. FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

On August 21, 2025, the FDA approved Ionis Pharmaceuticals’ donidalorsen (DAWNZERA), an RNA-targeted therapy to prevent hereditary angioedema (HAE) attacks in patients 12 years and older. Backed by pivotal OASIS-HAE and OASISplus phase 3 trials and long-term extension data, donidalorsen reduced monthly attacks by an average of 81% versus placebo. Patients switching from existing prophylactic treatments also saw further attack-rate reductions, and the therapy was well tolerated, with mostly mild injection site reactions.

8. FDA Issues CRL to Outlook Therapeutics' ONS-5010 for the Treatment of Wet AMD

On August 29, 2025, Outlook Therapeutics announced it had received a Complete Response Letter (CRL) from the FDA for its Biologics License Application for ONS-5010 (LYTENAVA), an ophthalmic formulation of bevacizumab in development for wet age-related macular degeneration (AMD). The agency cited the phase 3 NORSE EIGHT trial’s failure to meet its primary efficacy endpoint, noting insufficient evidence of effectiveness despite prior success in the NORSE TWO study.