Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration's new fast-track program ...

In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...

A plan to slash Food and Drug Administration drug review times is raising alarms at the public health agency that's been ...

A plan to slash drug review times at the Food and Drug Administration is sparking deep concerns among agency staffers and ...

Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains a ...

A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...

Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...