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

Can these microscopic cell messengers really help regrow lost hair or undo signs of aging? Here are the facts, according to experts.

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

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

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

Questionable things we eat everyday The blissful ignorance of glancing at an ingredient list and thinking, “Well, if I can’t ...

Analysts at BMO Capital Markets expect the lack of other exon-44-skiping therapies to facilitate a "smooth" approval process ...

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

An automated insulin delivery system received FDA approval for adults with type 2 diabetes on insulin therapy, according to an industry press release. The FDA approved an expanded indication for the ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...

The crackdown from the U.S. Food and Drug Administration could snuff out Breeze Smoke, a 6-year-old company based in Hazel ...