🇺🇸 Yorvipath in United States

FDA authorised Yorvipath on 9 August 2024

Marketing authorisations

FDA — authorised 9 August 2024

  • Application: NDA216490
  • Marketing authorisation holder: ASCENDIS PHARMA BONE
  • Local brand name: YORVIPATH
  • Indication: SOLUTION — SUBCUTANEOUS
  • Status: approved

The FDA approved Yorvipath, a new molecular entity, on 9 August 2024. This approval was granted to ASCENDIS PHARMA BONE under the standard expedited pathway. The indication for Yorvipath is not specified in the provided information.

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FDA

  • Marketing authorisation holder: ASCENDIS PHARMA BONE
  • Status: approved

Yorvipath in other countries

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

Other Nephrology approved in United States

Frequently asked questions

Is Yorvipath approved in United States?

Yes. FDA authorised it on 9 August 2024; FDA has authorised it.

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

ASCENDIS PHARMA BONE holds the US marketing authorisation.