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 ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

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 ...

Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...

Discover how drugs prevent, cure, and alleviate ailments. Learn about over-the-counter vs. prescription drugs and the ...

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 ...

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 ...

A senior Food and Drug Administration official on Friday said the agency will change its vaccine approval process, alleging that COVID-19 vaccination resulted in the deaths of 10 children.Video above: ...

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 ...

Zoliflodacin, which will be marketed under the name Nuzolvence, is the first new drug to uniquely target gonorrhea infections in decades, and the first developed as part of a public-private ...