Is DAY ONE BIOPHARMACEUTICALS, INC. FDA approved?

DAY ONE BIOPHARMACEUTICALS, INC. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are DAY ONE BIOPHARMACEUTICALS, INC.'s drugs manufactured?

The FDA register lists Brisbane, CA. Registered operations: finished drug manufacture.

What drugs does DAY ONE BIOPHARMACEUTICALS, INC. make?

2 products are listed under DAY ONE BIOPHARMACEUTICALS, INC. in the openFDA NDC Directory, most often as kit; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

DAY ONE BIOPHARMACEUTICALS, INC.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 2
Live patents: 4
Exclusivities: 1
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
DAY ONE BIOPHARMACEUTICALS, INC.	1800 Sierra Point Pkwy Ste 200, Brisbane, California (CA) 94005, United States (USA)	Finished drug manufacture	3023167609118074187

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
kit	1
tablet, film coated	1

Route	NDCs
oral	1

Labeller name on the listing	NDCs
day one biopharmaceuticals, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8293752	OJEMDAtovorafenib	substance, product	Aug 2031
10426782	OJEMDAtovorafenib	product	Jun 2035

Product	Exclusivity	Until
OJEMDATOVORAFENIB	ODE-478 Orphan drug	Apr 2031

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
OJEMDA	TOVORAFENIB	tablet, film coated, oral	82950-001NDA
OJEMDA	tovorafenib	kit	82950-012NDA

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Enquiry

Common questions

Is DAY ONE BIOPHARMACEUTICALS, INC. FDA approved?: DAY ONE BIOPHARMACEUTICALS, INC. holds 1 FDA-registered establishment in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are DAY ONE BIOPHARMACEUTICALS, INC.'s drugs manufactured?: The FDA register lists Brisbane, CA. Registered operations: finished drug manufacture.
What drugs does DAY ONE BIOPHARMACEUTICALS, INC. make?: 2 products are listed under DAY ONE BIOPHARMACEUTICALS, INC. in the openFDA NDC Directory, most often as kit; tablet, film coated. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.