🇺🇸 Lynozyfic in United States

FDA authorised Lynozyfic on 2 July 2025

Marketing authorisations

FDA — authorised 2 July 2025

Application: BLA761400
Marketing authorisation holder: RENGENERON PHARMACEUTICALS, INC.
Local brand name: LYNOZYFIC
Indication: SOLUTION — INJECTION
Status: approved

The FDA approved Lynozyfic, a new molecular entity, on July 2, 2025, under the standard expedited pathway. The marketing authorisation holder is RENGENERON PHARMACEUTICALS, INC. The application number for this approval is BLA761400. Lynozyfic is indicated for a specific type 1 condition.

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FDA

Marketing authorisation holder: RENGENERON PHARMACEUTICALS, INC.
Status: approved

Lynozyfic in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Lynozyfic approved in United States?

Yes. FDA authorised it on 2 July 2025; FDA has authorised it.

Who is the marketing authorisation holder for Lynozyfic in United States?

RENGENERON PHARMACEUTICALS, INC. holds the US marketing authorisation.