PROVENTION BIO INC — FDA SUPPL Approval for TZIELD (Not disclosed in the FDA record.)

Key facts

What was approved

FDA's record shows PROVENTION BIO INC as the sponsor of TZIELD, with the generic name recorded as Not disclosed in the FDA record. and dosage form INJECTABLE. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products such as vaccines, blood products, and therapies derived from living organisms. A BLA requires the sponsor to submit data demonstrating the product is safe, pure, and potent for its intended use. This specific application is submission type SUPPL (submission number 10) under application number BLA761183, with a submission status date of 20260612. 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.

Regulatory context

This application was reviewed under FDA's priority review pathway, granted when a product may offer a significant improvement over existing treatments, which typically targets a 6-month review goal measured from submission. A Biologics License Application (BLA) is the FDA pathway used to approve biologic products such as vaccines, blood products, and therapies derived from living organisms. A BLA requires the sponsor to submit data demonstrating the product is safe, pure, and potent for its intended use. FDA approval of an application does not itself guarantee ongoing marketing; sponsors remain subject to post-approval manufacturing inspections and adverse-event reporting requirements.

PROVENTION BIO INC’s FDA history

Argus HQ has recorded 1 total FDA action tied to PROVENTION BIO INC: 0 warning letters, 0 recalls, 1 approval record, and 0 Form 483 inspection citations.

Frequently asked questions

Does PROVENTION BIO INC have other FDA approval records?

This is the only FDA action Argus HQ has on file for PROVENTION BIO INC so far. Argus ingests new FDA records daily.

What is the FDA application number for this submission?

FDA application number BLA761183, submission 10.

What review priority did FDA assign?

FDA designated this submission as: PRIORITY.

What dosage form is TZIELD?

TZIELD is formulated as: INJECTABLE.

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