The U.S. government will address what it sees as an epidemic of chronic illness among American children, calling for changes ...

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

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 ...

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

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

Regulators sent about 100 warning letters this week to drug advertisers, including to Hims & Hers, a major online provider of ...

This article was reviewed by Craig Primack, MD, FACP, FAAP, FOMA. Weight loss can be a challenge, even for those who eat ...

After a more than decadelong process to bring the experimental drug elamipretide to market, the treatment’s approval has repeatedly hit roadblocks.

The new framework comes amid frail times for rare disease drug research in the US. The US Food and Drug Administration (FDA) ...