Frontier EdgeThursday, August 13, 2026

Celltrion Wins FDA Fast Track for Three Antibody-Drug Conjugate Cancer Candidates

Sourced from 4 publications

•Celltrion received FDA Fast Track designation for all three of its ADC-based anticancer drug candidates, according to Businesskorea.
•NeuroScientific confirmed a meeting with the US FDA regarding a planned Phase 2 trial of its StemSmart technology for refractory Crohn's disease.
•Definium is reportedly entering a Phase 3 trial for an LSD-based anxiety treatment, per a BioWorld preview with limited available detail.
•Fast Track designation provides procedural benefits such as rolling review but does not guarantee accelerated approval.

Sources

NeuroScientific locks in key US FDA meeting

Theage

NeuroScientific locks in key US FDA meeting

Smh

Definium’s LSD rings phase III bell again, this time in anxiety

bioworld

Celltrion ADC Candidates Win FDA Fast Track

Businesskorea

Was this story useful?

Curated from 4 sources. Every summary is reviewed for accuracy, but may still contain errors. We always link to original sources for verification.