The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce ...

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 ...

ADMA Biologics receives FDA approval for a process enhancing plasma production yields by 20%, boosting growth and capacity for its products. ADMA Biologics, Inc. has announced the U.S. FDA approval of ...

This completion is a crucial requirement in the approval process for a drug.

As 2026 approaches, now is the time to reflect on the victories from the year and the lessons to be taken moving forward.

Drugs approved by the FDA’s expanding program to expedite reviews for products in line with the Trump administration’s agenda ...

Patent reforms could address a problem that’s been driving rising prescription drug costs and create a more competitive ...

Both The U.S. Department of Health and Human Services (HHS) and the FDA announced the appointment of Richard Pazdur, M.D., as ...

Uncovering the dangers associated with a common surgical tool poses a question: Why is the FDA still following a 1976 process that systematically approves devices based on similarity to other devices ...

As medicine continues to develop, insurance companies continue to limit their treatment options and complicate their approval processes. Thus, the likelihood of insurance companies to initially deny ...

April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...