FDA Has Approved 46 Novel Drugs by October 9, Matching All of 2025
FDA's list of novel drug approvals shows 46 in 2026 through October 9. That equals the whole of 2025 and is 39% more than the same date last year. What the pace does and does not tell us.
By Martin DAVILA10/15/20265 On October 9, FDA approved Hovilpri (pritelivir) for herpes simplex lesions in immunocompromised adults. It was the 46th entry on the agency's 2026 list of novel drug approvals. The list for the whole of 2025 has 46 entries.
How fast is 2026 compared with earlier years?
With 46 approvals by October 9, 2026 already equals all of 2025 and runs 39% ahead of last year at this date.
Novel drug approvals on FDA CDER lists, counted through October 9 of each year (dark) and for the full year (light).
Source: FDA, Novel Drug Approvals for 2023, 2024, 2025 and 2026, counts recomputed from the dated lists. The 2026 list is still growing. The October 9 counts come from the dated lists; 2024 includes Itovebi on October 10, which falls just outside the cut. The list covers CDER only, so vaccines and gene therapies reviewed by CBER are not counted.
View data
| year | byOct9 | fullYear |
|---|---|---|
| 2023 | 40 | 55 |
| 2024 | 34 | 50 |
| 2025 | 33 | 46 |
| 2026 | 46 | — |
46 against 33 is 39% more than 2025 at the same date, 35% more than 2024 and 15% more than 2023. 2023 closed at 55, the highest of the four years, and 2026 needs nine more to match it with about twelve weeks left.
Where did the extra approvals come from?
Month by month, the 2026 list is uneven.
September was the busiest month of 2026 with nine approvals; January had one.
FDA novel drug approvals in 2026 by month of approval. October covers October 1 to 9.
Source: FDA, Novel Drug Approvals for 2026. Months sum to 46. Counted by us from the dated list.
View data
| month | approvals |
|---|---|
| Jan | 1 |
| Feb | 4 |
| Mar | 5 |
| Apr | 2 |
| May | 8 |
| Jun | 3 |
| Jul | 6 |
| Aug | 7 |
| Sep | 9 |
| Oct | 1 |
The second half is carrying the year: July to September has 22 approvals, against 23 in the whole first half. Approvals cluster on single days: three came on May 29 and two each on September 11 and September 25, so one day can move a monthly figure by a third.
What kind of drugs are they?
The list is broad. It includes first treatments for rare diseases such as Menkes disease, Alexander disease and MCT8 deficiency, cancer drugs such as daraxonrasib for metastatic pancreatic cancer, and large-market drugs such as orforglipron for obesity and enlicitide for LDL cholesterol. We did not classify all 46 by modality or disease area, so we do not claim a trend in what is being approved, only in how many.
What this does and does not show
A count of approvals measures what FDA finished, not how good the drugs are or how many reach patients. Approval timing is partly driven by review deadlines set months earlier, and a single month is noisy. We recomputed the counts from the dated lists on FDA pages, which we read through a text extraction tool, so a reviewer should spot-check them against the pages. A tracker we found (IntuitionLabs) reports 44 approvals for January to September 2026 against 32 for 2025, one fewer than the 45 we counted for 2026; we could not resolve the difference. We also cannot say from this data why the pace rose.
Sources
- FDA, Novel Drug Approvals for 2026, as of October 9, 2026: 46 entries with dates.
- FDA, Novel Drug Approvals for 2025 (46), 2024 (50) and 2023 (55).
- IntuitionLabs, FDA Novel Drug Approvals 2026 tracker: second count for January to September.
- Our earlier analysis: What FDA approved in 2024, and why the mix matters.
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