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.
In early 2025, the FDA was rocked by sweeping layoffs and leadership turnover, raising questions about whether the agency ...
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 integration of Artificial Intelligence (AI) in various sectors has been nothing short of transformative, and now, it’s poised to revolutionize the pharmaceutical industry. The U.S. Food and Drug ...
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 Food and Drug Administration (FDA) is looking to AI to solve the problem of lengthy approval processes, as the Trump administration invests in even more automation amid thousands of federal worker ...
Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...
FDA approval describes when the Food and Drug Administration (FDA) deems a medical product safe and effective for its intended use based on scientific data and testing. Before people use a medical ...
Jan 15 (Reuters) - The U.S. Food and Drug Administration has delayed reviews of two drugs chosen for the Trump administration ...
Drugmakers told the FDA that inflexible post-approval change requirements are among the top regulatory barriers to the reshoring of pharmaceutical manufacturing.