Are Trump/DOGE cuts to FDA staff impacting drug approval timelines?
It seems like the answer is now ‘yes’. EndPoints reports: Stealth BioTherapeutics said the FDA would not meet its Tuesday deadline for approving or rejecting the company’s drug, elamipretide. It had been seeking regulatory clearance of elamipretide for a rare disease called Barth syndrome, which affects only about 150 people in the US and causes…