Legal questions swirl around FDA's new expedited drug program, including who should sign off

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

Takeaways from the AP's report on turmoil surrounding the FDA's new fast-track drug program

Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Fierce Pharma

Drug approvals went from crawl to sprint in 2025

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

Exclusive: US FDA delays two drug reviews in new voucher program after safety, efficacy concerns

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

Fast-tracked drug approvals pose safety risks, study shows

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

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...
VegOut Magazine

Your dog could live longer—new longevity drug just passed FDA safety approval

For pet owners who dread how short a dog's life can be, a beef-flavored tablet could offer real hope for more time together.