Q3 2025 Management View CEO Mark Goldsmith opened the call highlighting the company's ongoing commitment to “revolutionizing ...
Panelists discuss how RWE informs treatment and safety decisions for special populations such as patients with ECOG PS 2 with ...
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Biohaven regarding the New Drug Application (NDA) for troriluzole for the treatment of adults with spinocerebellar ...
After a three-month delay, the FDA has now rejected an approval request based on the RWE. According to Biohaven, the FDA’s complete response letter “cited issues that can be inherent to real-world ...
Q3 2025 Management View Jay Duker, President and CEO, described the quarter as one of “tremendous progress” and highlighted ...
Baricitinib (Olumiant; Eli Lilly), an oral Janus kinase (JAK) 1/2 inhibitor, led to significant scalp, eyelash, and eyebrow hair regrowth at 52 weeks in adolescents with severe alopecia areata, ...
The brain drug developer plans to slash R&D expenses by about 60% in the wake of the FDA surprisingly rejecting its rare disease drug Vyglxia.