CymaBay has taken a look at its ongoing midstage test for its liver med seladelpar, and is happy with what it sees.

Officials are making the cash available to implement recommendations the U.K. sees establishing it as the first port of call for drug development.

Officials knocked back the filing after phase 3 data linked the sclerostin-targeting antibody to an increased risk of cardiovascular adverse events.

Allena Pharma has been granted orphan status by the FDA for a drug to treat primary hyperoxaluria.

The FDA has hit Ocular Therapeutix with another complete response letter, wiping 30% off the company's stock.

Amicus can now submit its rare disease drug for review, a year after being blocked.

An FDA greenlight for sickle cell therapy Endari has put developer Emmaus into the spotlight, but commercializing the drug could be challenging.

Ahead of the first-ever FDA AdComm for a CAR-T medication, the agency says experts should focus on the safety side of the new med.

The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up plans to speed up the drug regulation process.

Regulatory