An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

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

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

In May 2025, the FDA approved mepolizumab (Nucala) as a treatment for chronic obstructive pulmonary disease (COPD). Before any drug gets near a pharmacy shelf, it starts with years of basic science ...