The FDA has made it clear that the primary bar for NTM drug approval is patient ... seek FDA input on our selection of QOL-B as the new primary efficacy endpoint prior to unblinding the Phase ...

The FDA has ... for NTM drug approval is patient-reported improvement in NTM symptoms. Our recent statistical analysis plan submission provides the opportunity to seek FDA input on our selection of ...

Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint ... AML. This includes alignment on potential pathways for accelerated ...

Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline intensive ...

Bronchiectasis (QOL-B) respiratory domain patient reported outcome (PRO) instrument as the primary efficacy endpoint ... The FDA has made it clear that the primary bar for NTM drug approval ...

Alignment reached with FDA and EMA on key aspects of the KOMET-017 protocol including use of MRD-negative CR endpoint for potential U.S. accelerated approval pathway in frontline ... through the ...

Technologies announces its role in supporting Autolus Therapeutics’ FDA approval for AUCATZYL, a recently approved CAR T therapy.

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with ...