Biohaven's NDA for Troriluzole was accepted by the FDA, potentially leading to approval in Q3 2025. Click here to find out ...
Biohaven Ltd. (NYSE: BHVN) (Biohaven or the Company), today announced that the US Food and Drug Administration (FDA) has ...
Biohaven (BHVN) announced that the FDA has accepted for review the company’s New Drug Application, or NDA, for troriluzole for the treatment of ...
The Food and Drug Administration (FDA) has accepted for Priority Review the New Drug Application (NDA) for troriluzole for the treatment of adults with ...
Biohaven has won Food and Drug Administration priority review for its application seeking approval of troriluzole for adults with spinocerebellar ataxia, a group of rare, genetic neurological ...
Troriluzole could become the first FDA-approved treatment for SCA, aiming to address a critical unmet medical need. The FDA's decision on the NDA is anticipated by the third quarter of 2025.
Troriluzole demonstrated a 50-70% slowing of SCA disease progression on the primary and secondary outcome measures at the 3-year endpoint in a real-world evidence (RWE) study. Troriluzole has a ...