"Novel" drugs are new drugs never before approved or marketed in the U.S. See Drugs@FDA for information about all of CDER’s approved drugs and biological products.
FDA Novel Drug Therapy Approvals for 2026
No.
Drug Name
Active Ingredient
Approval Date
FDA-approved use on approval date*
1.
Zycubo
copper histidinate
1/12/2026
To treat Menkes disease
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