Makary pointed to three bottlenecks: hospital contracting; ethical reviews and approvals; and the Investigational New Drug ...

For decades, government intervention into the health care sector has increased at the expense of individual freedom. This disturbing trend is especially prevalent when it comes to the antiquated drug ...

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 ...

Scientific, political pressures colliding at FDA, delaying rare disease treatment for patients who have few or no options, experts said at CNBC Cures Summit.

In a major shift, the US Food and Drug Administration is relaxing a long-standing drug approval requirement for common diseases.

The government has expedited the drug approval process by allowing immediate laboratory testing post-application, bypassing preliminary scrutiny. The Central Drugs Standard Control Organization's new ...

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 proposed new guidelines for approving experimental therapies for rare diseases without large group studies.