FDA — authorised 21 December 2018
- Marketing authorisation holder: STEMLINE THERAPEEUTICS INC
- Status: approved
🇺🇸 Molecule 129 in United States
FDA authorised Molecule 129 on 21 December 2018
Marketing authorisations
FDA — authorised 21 December 2018
- Application: BLA761116
- Marketing authorisation holder: STEMLINE THERAPEUTICS INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
Molecule 129 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 Molecule 129 approved in United States?
Yes. FDA authorised it on 21 December 2018; FDA authorised it on 21 December 2018.
Who is the marketing authorisation holder for Molecule 129 in United States?
STEMLINE THERAPEEUTICS INC holds the US marketing authorisation.