FDA Novel Drug Approvals — 5-Year Dashboard
2021–2026 · Novel drugs only (NMEs + new biologics) · Source: FDA CDER · mediumturquoise-koala-132434.hostingersite.com
Live tracker
Annual novel drug approvals 2021–2026
By therapeutic area
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drugs
FDA Novel Drug Approvals
Source: fda.gov/drugs/novel-drug-approvals-fda · Click any row to learn more
No.
Drug Name
Active Ingredient
Approval Date
FDA-Approved Use on Approval Date*
Therapeutic Area
* Listed use is for presentation only. See Drugs@FDA for full prescribing information.
Source: fda.gov/drugs/novel-drug-approvals-fda · Verified from FDA press releases · mediumturquoise-koala-132434.hostingersite.com · Updated March 2026
Source: fda.gov/drugs/novel-drug-approvals-fda · Verified from FDA press releases · mediumturquoise-koala-132434.hostingersite.com · Updated March 2026
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