A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...

Researchers urge inclusion of negative studies on drug labels ...

The Food and Drug Administration (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

A first-of-its-kind drug may slow the progression of Huntington's disease, a rare, fatal, neurodegenerative disorder.

When the US Food and Drug Administration (FDA) approves a drug, its primary concern is with the product's safety, efficacy and quality. But a secondary concern is what is known as "drug lag"—the time ...

The Food and Drug Administration is a government agency that regulates certain food, drugs, cosmetics, and medical products.

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

The FDA wants to withdraw approval of Amgen’s drug after years on the market. The company is defending it.

Accelerated approval of semaglutide 7.2 mg establishes a higher-dose, once-weekly GLP-1 RA option for long-term weight reduction under the FDA’s National Priority Voucher framework. STEP UP (n=1407) ...

The pressure is building for the U.S. Food and Drug Administration (FDA) to take steps to facilitate making more drugs available over-the-counter (OTC) that currently require a prescription. As part ...