The agency is proposing a requirement that companies submit data when self-affirming an additive is safe for consumption.

FDA launches Rare Disease Evidence Principles to guide therapy reviews, offering new pathways for approval while raising ...

The U.S. Food and Drug Administration on Wednesday proposed a new process to streamline the approval of drugs targeting rare ...

Makary announced plans for a new rare disease pathway in an April episode of "The Megyn Kelly Show." The proposal follows ...

Accelerated Approval (AA) pathway, initially established in 1992 during the HIV/AIDS epidemic to provide faster access to ...

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 ...

Microbot Medical describes its product as "intended for use in the remote delivery and manipulation of guidewires and ...

Scientists reached a major milestone in animal-to-human transplant research as the FDA approved the first human clinical ...

U.S. regulators approved updated COVID-19 shots Wednesday but limited their use for many Americans — and removed one of the two vaccines available for young children. The new shots from Pfizer, ...

FDA-approved clinical trial will allow Mass General Hospital and eGenesis to involve transplant patients nationwide.

The trial will evaluate the effectiveness of the nsPFA cardiac surgical system during concurrent surgical procedures.