FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...

The FDA has determined that REMS programs are no longer necessary to ensure the benefits of these CAR T cell immunotherapies outweigh their risks.

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

The Food and Drug Administration will consider drug affordability when granting companies new vouchers that speed up approvals of some treatments, the agency's Commissioner Marty Makary told CNBC.

The FDA typically does not make complete response letters public, citing confidentiality, putting the onus on the drug companies to share that information, which they often do selectively.

FDA employees are spooked by increasing political involvement in regulatory decisions, frustrated by the impact of cuts to administrative staff who supported drug reviews and inspections, and fed ...

Georgia's congressional delegation is advocating for FDA reconsideration of the drug elamipretide for Hope Filchak.