REGENERON PHARMACEUTICALS, INC — FDA ORIG Approval for Unspecified (Not disclosed in the FDA record.)

Key facts

Regulatory context

This application was reviewed under FDA's ORIG submission pathway. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

What was approved

FDA's record shows REGENERON PHARMACEUTICALS, INC as the sponsor of Unspecified, with the generic name recorded as unspecified and dosage form unspecified dosage form. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products (such as vaccines, blood products, and cell/gene therapies), requiring evidence of safety, purity, and potency along with manufacturing-process validation specific to biologic manufacturing. This specific application is submission type ORIG (submission number 1) under application number BLA761508, with a submission status date of 20260819. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. This record is drawn directly from FDA's own approvals database rather than from company press materials. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission. FDA publishes approval and submission records so physicians, competitors, and investors can track which sponsors and products have cleared a given regulatory pathway. An approval reflects FDA's determination on the application as submitted; any post-approval changes to manufacturing, labeling, or use typically require a separate supplemental submission.

Regeneron Pharmaceuticals Inc’s FDA history

Argus HQ has recorded 3 total FDA actions tied to Regeneron Pharmaceuticals Inc: 0 warning letters, 2 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

Does REGENERON PHARMACEUTICALS, INC have other FDA approval records?

Yes. Argus HQ has recorded 3 total FDA actions tied to REGENERON PHARMACEUTICALS, INC, including 1 approval record.

What is the FDA application number for this submission?

FDA application number BLA761508, submission 1.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is Unspecified?

Unspecified is formulated as: unspecified dosage form.

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