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.

Novartis’ CAR-T cancer therapy has won the unanimous support of the FDA’s advisory committee, setting it up to win approval by October 3.

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.

Shire has obtained a preliminary injunction to stop Roche spreading “inaccurate and misleading” statements about clinical trial data.

Regulatory