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.
