Health system pharmacists and clinicians are monitoring a wave of drug approvals expected throughout 2026, including first-in-class therapies and expanded uses of existing drugs with implications for hospital formularies, prescribing protocols and patient access.
A report published Jan. 8 by GoodRx, “FDA Approval Watch: New Drugs, Vaccines, and Therapies Pending Approval in 2026” outlines several high-impact medications currently under FDA review.
Here are key therapies to watch this year:
1. Anaphylm for anaphylaxis: The sublingual epinephrine film may offer the first needle-free, device-free alternative for treating severe allergic reactions. An FDA decision is expected by Jan. 31.
2. Dupixent for allergic fungal rhinosinusitis: Already approved for multiple inflammatory conditions, the biologic is under review for treating AFRS, a chronic sinus disorder driven by type 2 inflammation. A decision is expected by Feb. 28.
3. Sotyktu for psoriatic arthritis: The once-daily oral TYK2 inhibitor is currently approved for plaque psoriasis. If approved by March 6, it would offer a noninjectable option for psoriatic arthritis.
4. Orforglipron for weight loss: A once-daily oral GLP-1 receptor agonist, orforglipron could become an alternative to injectable therapies. The drug is under priority review, with an FDA decision expected in March.
5. Higher-dose Wegovy (7.2 mg): Novo Nordisk’s proposed expanded dosing could offer up to 21% body weight reduction over 72 weeks. A decision is expected in the first quarter under the FDA’s accelerated review program.
6. Afrezza for pediatric diabetes: Already approved for adults, the inhaled insulin may become the first needle-free insulin option for children ages 4 and older. A decision is expected by May 29.
7. Cytisinicline for smoking cessation: If approved, the non-nicotine pill would be the first new FDA-approved smoking cessation medication in nearly 20 years. A decision is expected by June 20.
8. Baxdrostat for resistant hypertension: An oral aldosterone synthase inhibitor, Baxdrostat is under priority review for patients who haven’t responded to standard therapies. A decision is expected in the second quarter.
9. Icotrokinra for plaque psoriasis: The oral IL-23 blocker may become the first of its class not delivered by injection. An approval could come in the first half of the year.
10. CagriSema for weight loss: A combination of cagrilintide and semaglutide, the GLP-1/amylin analog is under FDA review with a decision expected later this year.
11.Awiqli for Type 2 diabetes: A once-weekly basal insulin injection under review for adults with Type 2 diabetes. If approved, it would significantly reduce injection burden compared to daily insulin. A decision is expected in 2026.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.