Healthcare ranking
Top 10 companies by FDA new drug application approvals 2026
Avyxa received the most FDA new drug application approvals between 1 November 2025 and 31 October 2026, with 5 approvals. The list ranks companies by the number of new drug applications approved for the first time in that period.
Top 10 at a glance
The full list
| Rank | Company | Headquarters | FDA new drug application (NDA) approvals (approvals) |
|---|---|---|---|
| 1 | Avyxa | United States | 5 |
| 2 | AstraZeneca | United Kingdom | 3 |
| 3 | Azurity Pharmaceuticals | United States | 2 |
| 3 | Baxter | United States | 2 |
| 3 | Bayer | Germany | 2 |
| 3 | Fresenius Medical Care | Germany | 2 |
| 3 | GSK | United Kingdom | 2 |
| 3 | Gilead Sciences | United States | 2 |
| 3 | Johnson & Johnson (Janssen) | United States | 2 |
| 3 | Merck & Co. (MSD) | United States | 2 |
| 3 | Takeda | Japan | 2 |
| 3 | Vanda Pharmaceuticals | United States | 2 |
How this list is built
We counted new drug applications whose original submission was approved between 1 November 2025 and 31 October 2026; supplements and tentative approvals are not counted, and each application counts once whatever its number of strengths. Applications filed under subsidiaries and name variants are merged into the parent company ("AVYXA HOLDINGS" and "AVYXA HOLDINGS, LLC." are counted as Avyxa). Companies with the same count share a rank, and all companies tied at the last place are shown. New drug applications include new forms of existing medicines, so this is not a count of novel drugs.
Every position is set by the data alone, by the same rules for every company. Spotted something to update? Write to info@stratummarketresearch.com with the list and the line, and we correct it within two working days.
For ranked companies: a free badge
Ranked companies can show this badge on their website, in a press release or on LinkedIn at no cost. Pick your company, then copy the code.
Frequently asked questions
Who is number one in the companies by FDA new drug application approvals ranking?
Avyxa ranks first with 5 approvals (1 November 2025 to 31 October 2026).
How is this ranking calculated?
We counted new drug applications whose original submission was approved between 1 November 2025 and 31 October 2026; supplements and tentative approvals are not counted, and each application counts once whatever its number of strengths. Applications filed under subsidiaries and name variants are merged into the parent company ("AVYXA HOLDINGS" and "AVYXA HOLDINGS, LLC." are counted as Avyxa). Companies with the same count share a rank, and all companies tied at the last place are shown. New drug applications include new forms of existing medicines, so this is not a count of novel drugs.
Can a company pay to rank higher?
Positions come only from the counts described above, and inclusion is free. Every company is ranked by the same rules.
How often is the ranking updated?
Every list is recomputed each quarter from the latest public records, and the update date is printed on the page.
Can a ranked company use the badge?
Yes. Every ranked company can use the free web badge on this page on its website, in press releases and on social media.
Custom research
Looking for a specific market?
Tell us the market, the region and the decision you are making. We reply within one working day with a scope and a date.