Exclusive: US FDA cleared pricey rare disease drug over reviewer objections

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...
BioSpace

Biohaven Cuts R&D Spending by 60% After FDA Rejection of Drug for Rare Neurodegenerative Disease

Biohaven is proposing troriluzole for the treatment of spinocerebellar ataxia, a group of rare, genetic diseases that lead to ...
Investing.com South Africa

Biohaven stock plummets after FDA rejects SCA treatment

Investing.com -- Biohaven (NYSE:BHVN) stock fell 44% after the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company’s New Drug Application for VYGLXIA ...
TipRanks on MSN

FDA complete response letter cites issues in Biohaven Vyglxia NDA

Biohaven (BHVN) announced that it has received a complete response letter from the FDA for the new drug application seeking approval of Vyglxia ...

FDA approves treatment for rare disease, offering hope to Florence family

This week, the Food and Drug Administration approved the first-ever treatment for people living with an extremely rare ...