LOS ANGELES (KABC) -- The Food and Drug Administration's approval process is one of the most stringent in the world, but now some experts are questioning newer drugs that go through a quicker review.

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 ...

The U.S. Food and Drug Administration will take steps to streamline the process to develop generic versions of complex biological drugs, the agency announced Wednesday. The changes are meant to ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...

FDA commissioner Marty Makary said it would be “magical” for consumers to see prescription drugs on pharmacy shelves instead ...