US FDA cleared pricey rare disease drug over reviewer objections

The FDA declined to consider elamipretide for full approval in 2021 and rejected the company's application in May of 2025 ...

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 ...
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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.