BioPharma Dive

Knocked back by the FDA, Biohaven turns to major cost cuts

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.

Biohaven sinks as FDA declines to approve lead drug; BofA downgrades

Shares of Biohaven (BHVN) plunged ~37% to reach a new 52-week low on Wednesday after the company said the U.S. FDA issued a ...

US FDA cleared pricey rare disease drug over reviewer objections

FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

Ironwood wins FDA label expansion for bowel disease drug developed with AbbVie

The U.S. Food and Drug Administration on Wednesday approved Linzess (linaclotide), developed by Ironwood Pharmaceuticals ...
BioSpace

FDA Overruled Reviewers in Approving Stealth’s Barth Syndrome Treatment

According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.