Here are some of the most recently approved drugs as of October 2025, which can be found in the databases of the U.S. Food and Drug Administration (FDA).
Recent FDA drug approvals (September–October 2025)
- Jascayd (nerandomilast): FDA-approved to treat idiopathic pulmonary fibrosis, a severe lung disease.
- Rhapsido (remibrutinib): First Bruton tyrosine kinase inhibitor approved for chronic spontaneous urticaria (CSU).
- Keytruda Qlex (pembrolizumab / berahyaluronidase alfa-pmph): A new subcutaneous formulation of Keytruda, approved for multiple solid tumor types.
- Inluriyo (imlunestrant): Approved for advanced or metastatic breast cancer that is estrogen receptor-positive, HER2-negative, and has an ESR1 mutation.
- Inlexzo (gemcitabine intravesical system): Approved for high-risk non-muscle invasive bladder cancer (NMIBC).
How to find comprehensive lists of approved medications
Due to the vast number of approved medications, a complete list is not available in a simple format. You can find comprehensive lists and searchable databases from the following sources:
- Drugs@FDA: Search for information on most FDA-approved prescription, generic, and over-the-counter drug products.
- Orange Book: Identifies drug products approved by the FDA on the basis of safety and effectiveness.
- Purple Book: Contains information about FDA-approved biological products, including biosimilars and interchangeable products.
- National Drug Code (NDC) Directory: Searchable database with information on both finished and unfinished drugs.
To look up medications covered by your insurance plan, consult your plan’s specific formulary. These lists are often updated monthly. For example, the Medi-Cal Rx Contract Drugs List is available online.