Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

In the first 6 months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under ...

In last week’s Supreme Court ruling, the justices allowed federal agencies to proceed with their reduction-in-force, or RIF, ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

Marcel Botha discusses whether AI can truly be used to replace laid off human workers at FDA.

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

HHS faces other legal challenges over its workforce cuts. A class-action lawsuit in the U.S. Court for the District of Columbia claims the department relied on “hopelessly error-ridden” data when it ...