FDA Approval History
This list consists of medications tracked by Drugs.com through the application and approval process at the U.S. Food and Drug Administration (FDA). Where possible, we have assembled information in chronological order to show the history of a medication. May only show partial information and does not include non-US drug approvals. For information about non-US medications, please visit the international drugs section.
Latest drug approvals
- Lynozyfic (linvoseltamab-gcpt) - July 02, 2025
- Harliku (nitisinone) - June 19, 2025
- Yeztugo (lenacapavir) - June 18, 2025
- Andembry (garadacimab-gxii) - June 16, 2025
- Arynta (lisdexamfetamine dimesylate) - June 16, 2025
- Zusduri (mitomycin) - June 12, 2025
- Ibtrozi (taletrectinib) - June 11, 2025
- Enflonsia (clesrovimab-cfor) - June 09, 2025
- Widaplik (amlodipine, indapamide and telmisartan) - June 05, 2025
- Xifyrm (meloxicam) - June 05, 2025
- mNEXSPIKE (COVID-19 Vaccine, mRNA) - May 30, 2025
- Khindivi (hydrocortisone) - May 28, 2025
- Tryptyr (acoltremon) - May 28, 2025
- Yutrepia (treprostinil) - May 23, 2025
- Starjemza (ustekinumab-hmny) - May 22, 2025
- Nuvaxovid (COVID-19 Vaccine, Adjuvanted) - May 16, 2025
- Brekiya (dihydroergotamine mesylate) - May 14, 2025
- Emrelis (telisotuzumab vedotin-tllv) - May 14, 2025
- Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) - May 08, 2025
- Atzumi (dihydroergotamine mesylate) - April 30, 2025