The FDA has communicated to Stealth BioTherapeutics that it would not meet elamipretide’s PDUFA target date for the treatment of Barth syndrome.

To REMS, or not to REMS. That, apparently, was the question for Cytokinetics, which has seen any potential approval for its ...

Shares of biopharmaceutical company Cytokinetics were trading in the red in the after-hours market following news the Food and Drug Administration extended the prescription drug user fee act action ...