What are “Novel” Drugs?

“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 2025

No.	Drug Name	Active Ingredient	Approval Date	FDA-approved use on approval date*
7.	Qfitlia	fitusiran	3/28/2025	To prevent or reduce the frequency of bleeding episodes in hemophilia A or B Press Release
6.	Blujepa	gepotidacin	3/25/2025	To treat uncomplicated urinary tract infections
5.	Romvimza	vimseltinib	2/14/2025	To treat symptomatic tenosynovial giant cell tumor for which surgical resection will potentially cause worsening functional limitation or severe morbidity
4.	Gomekli	mirdametinib	2/11/2025	To treat neurofibromatosis type 1 who have symptomatic plexiform neurofibromas not amenable to complete resection
3.	Journavx	suzetrigine	1/30/2025	To treat moderate to severe acute pain Press Release
2.	Grafapex	treosulfan	1/21/2025	For use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation for acute myeloid leukemia and myelodysplastic syndrome
1.	Datroway	datopotamab deruxtecan-dlnk	1/17/2025	To treat unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease

*The listed “FDA-approved use” on this website is for presentation purposes only. To see the FDA-approved conditions of use [e.g., indication(s), population(s), dosing regimen(s)] for each of these products, see the most recent A-approved Prescribing Information (click on the Drug Name).

Content current as of:

03/31/2025

Source

Medically Reviewed By: Felicia Eddings, Pharm.D.

Clinical :: Oncology :: Nuclear :: Geriatric :: Regulatory :: Technology :: Consulting

"My passion is helping businesses, small and large, perform at their best." - Felicia Udoji-Eddings, Pharm.D.

Dr. Felicia Udoji-Eddings is the Founder and CEO of The Health Pals Company, a vertically integrated Healthcare System. As an experienced Clinical Pharmacy Leader, Pharmacy Consultant, Healthcare Executive, and Licensed Pharmacy Practitioner with deep backgrounds in Information Technology (IT), Scientific Research, and Business Management. Dr. Udoji-Eddings has a strong track record of exceptional performance in different business environments. A skilled Business Strategist, Dr. Udoji-Eddings has tackled complex problems and helped several organizations refocus their strategy in tough economic times. As a highly motivated and proactive individual, Felicia enjoys working with teams, in various capacities, to facilitate positive outcomes.

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