Is Iovance Biotherapeutics, Inc. FDA approved?

Iovance Biotherapeutics, 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 Iovance Biotherapeutics, Inc.'s drugs manufactured?

The FDA register lists Philadelphia, PA. Registered operations: analytical testing, finished drug manufacture.

What drugs does Iovance Biotherapeutics, Inc. make?

2 products are listed under Iovance Biotherapeutics, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; suspension. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Iovance Biotherapeutics, Inc.

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

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Registered sites: 1
Active NDC listings: 2
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Iovance Biotherapeutics Manufacturing LLCRegistrant: Iovance Biotherapeutics, Inc.	300 Rouse Blvd, Philadelphia, Pennsylvania (PA) 19112, United States (USA)	Analytical testing, Finished drug manufacture	3020882632118423955

Catalogue

Drug listings by form and route

2 active NDC listings: 1 cellular therapy, 1 human prescription drug. By marketing category: BLA 2.

Dosage form	NDCs
injection, powder, lyophilized, for solution	1
suspension	1

Route	NDCs
intravenous	2

Labeller name on the listing	NDCs
iovance biotherapeutics inc.	1
iovance biotherapeutics, inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AMTAGVI	lifileucel	suspension, intravenous	73776-001BLA
PROLEUKIN	aldesleukin	injection, powder, lyophilized, for solution, intravenous	73776-022BLA

Neighbours

Registered in the same town

Catalent Pharma Solutions Inc.Philadelphia, PA
AstraZeneca PLCPhiladelphia, PA
Frontida BioPharm, LLCPhiladelphia, PA
Medical Products Laboratories, Inc.Philadelphia, PA
Premier Dental Products CompanyPhiladelphia, PA
Spark Therapeutics, Inc.Philadelphia, PA
Trustees of the University of PennsylvaniaPhiladelphia, PA
USWM CT, LLCPhiladelphia, PA

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Enquiry

Common questions

Is Iovance Biotherapeutics, Inc. FDA approved?: Iovance Biotherapeutics, 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 Iovance Biotherapeutics, Inc.'s drugs manufactured?: The FDA register lists Philadelphia, PA. Registered operations: analytical testing, finished drug manufacture.
What drugs does Iovance Biotherapeutics, Inc. make?: 2 products are listed under Iovance Biotherapeutics, Inc. in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; suspension. 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.