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

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

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

The agency's two main review offices will work together to flexibly evaluate medicines for serious conditions that affect ...

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

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

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

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening the ...

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

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 ...