2025 drug approvals, breakthroughs, and trends

Summary

• The Food and Drug Administration (FDA) approved 46 novel drugs in 2025, four fewer than the amount approved in 2024.
• December was the busiest month for approvals with seven approved drugs.

 

Key therapeutic areas

A number of cancer drugs were approved, including five for non-small cell lung cancer and two for breast cancer.  Other cancer medicines targeted nasopharyngeal carcinoma, ovarian cancer, and multiple myeloma.

In addition to cancer therapies, some of the newly approved drugs were:

• Eye conditions: for treatment of symptoms of dry eye disease, for treatment of presbyopia, and for treatment of macular telangiectasia type 2
• Rare conditions: for treatment of thymidine kinase 2 deficiency, for treatment of acromegaly in adults, and for treatment of non-cystic fibrosis bronchiectasis
• Skin diseases: for treatment of chronic spontaneous urticaria and for treatment of moderate to severe chronic hand eczema
• Women’s health: for treatment of moderate to severe vasomotor symptoms due to menopause and for treatment of urinary tract infections.

Highlights

1. The first non-opioid medicine for treatment of moderate to severe pain in 20 years was approved in January.
2. The first hormone-free IUD in over 40 years was approved in February.
3. The first new treatment for gonorrhea in over 30 years was approved in December.
4. The first oral GLP-1 therapy for chronic weight management in adults was approved in December.

2026 outlook

Several new drugs could be approved this year, including:

1. Brimochel PF to treat presbyopia
2. Orforglipron to treat obesity
3. Oveporexton to treat narcolepsy
4. Zilganersen to treat Alexander disease, a rare neurological condition
5. Baxdrostat to treat high blood pressure
6. Sparsentan to treat focal segmental glomerulosclerosis, a kidney disease

References

Novel Drug Approvals for 2025. Food and Drug Administration. January 2, 2026.

Novel Drug Approvals for 2024. Food and Drug Administration. July 14, 2025.

Novel Drug Approvals for 2023. Food and Drug Administration. January 10, 2025.

Novel Drug Approvals for 2022. Food and Drug Administration. January 2, 2025.

Novel Drug Approvals for 2021. Food and Drug Administration. May 22, 2024.

Aamir, Muhammad Bilal, Kumari, Pinkey, Altaf, Muhammad Taha, et al. FDA approves Journavx (Suzetrigine) as the first non-opioid treatment for moderate to severe acute pain. Annals of Medicine and Surgery. October 13, 2025.

McGovern, Gillian. FDA Approves Miudella, First Hormone-Free, Copper IUD in Over 40 Years. Pharmacy Times. February 26, 2025.

Branswell, Helen. FDA approves first new gonorrhea drug in decades. Stat News. December 11, 2025.

Tirrell, Meg. With FDA approval of Wegovy pill, new era of oral GLP-1 weight loss drugs begins. CNN. December 22, 2025.

Cooper, Justin. FDA accepts new drug application for Brimochol PF for presbyopia treatment. Healio. June 9, 2025.

Beasley, Deena. Lilly weight-loss pill could be FDA-approved by year-end. Reuters. September 16, 2025.

Fidler, Ben. Takeda to seek approval of new kind of narcolepsy drug after study data. BioPharma Dive. July 14, 2025.

Ionis receives U.S. FDA Breakthrough Therapy designation for zilganersen for Alexander disease (AxD). Ionis Pharmaceuticals. December 2, 2025.

Aripaka, Pushkala. AstraZeneca to seek approval for blood pressure drug by year-end. Reuters. August 30, 2025.

Ernst, Diana. FDA Drug Approval Decisions Expected in January 2026. Cardiology Advisor. December 22, 2025.