Page updated ·next FDA decision on the calendar·Data as of Nov 12, 2026 2:24 AM ET
Every FDA drug approval by month from Drugs@FDA: 114 new drug and biologic applications approved so far in 2026, each month listing every approval with its sponsor, action day and letter.
November 2026: 0 new applications, 1 efficacy supplement
October 2026: 16 new applications, 25 efficacy supplements
September 2026: 16 new applications, 16 efficacy supplements
August 2026: 12 new applications, 14 efficacy supplements
July 2026: 16 new applications, 19 efficacy supplements
June 2026: 7 new applications, 22 efficacy supplements
May 2026: 15 new applications, 21 efficacy supplements
April 2026: 4 new applications, 22 efficacy supplements
March 2026: 10 new applications, 20 efficacy supplements
February 2026: 13 new applications, 22 efficacy supplements
January 2026: 5 new applications, 12 efficacy supplements
December 2025: 17 new applications, 25 efficacy supplements
November 2025: 8 new applications, 23 efficacy supplements
October 2025: 20 new applications, 30 efficacy supplements
September 2025: 15 new applications, 13 efficacy supplements
August 2025: 16 new applications, 11 efficacy supplements
July 2025: 15 new applications, 17 efficacy supplements
June 2025: 15 new applications, 25 efficacy supplements
May 2025: 8 new applications, 22 efficacy supplements
April 2025: 17 new applications, 33 efficacy supplements
March 2025: 11 new applications, 24 efficacy supplements
February 2025: 15 new applications, 14 efficacy supplements
January 2025: 7 new applications, 16 efficacy supplements