Programs assist in the fast track of drugs for serious conditions. FDA has issued draft guidance to create four programs to expedite development and review of drugs intended to treat serious medical ...

The FDA proposes to use the RWE Program to guide generation of data in support of approval for new indications or to help support post-approval study requirements. At the end of 2018, the FDA released ...

Psychedelics have demonstrated significant progress, generating enthusiasm across the neuroscience industry and leading to successful independent companies. Rare neuromuscular and neurodevelopmental ...

The head of the Food and Drug Administration on Tuesday announced an overhaul of the agency’s food safety and nutrition division, vowing that a new structure will better protect consumers and the U.S.

On Jan. 13, 2012, FDA announced it had completed, and transmitted to Congress, its recommendations for three user fee programs including the fifth authorization of the Prescription Drug User Fee Act ...

Alzheimer's patients received great news in January when the FDA granted accelerated approval to lecanemab, a new treatment for the fatal dementia. The FDA's accelerated approval program expedites the ...

(Reuters) - Eli Lilly's experimental weight-loss pill could be fast-tracked under a one- to two-month review process recently launched by the U.S. Food and Drug Administration, several Wall Street ...

This webinar will discuss four FDA expedited programs intended to facilitate and expedite development, review and approval of new drugs to address unmet medical needs in the treatment of serious and ...

SAN FRANCISCO, CA / ACCESS Newswire / September 30, 2025 / Jaguar Health (NASDAQ:JAGX) today announced that Jaguar family company Napo Pharmaceuticals (Napo) is providing the company's novel ...

FREMONT, Calif. - Tivic Health Systems, Inc. (NASDAQ:TIVC), a micro-cap therapeutics company currently valued at $2.17 million, recently held meetings with senior officials at the White House and the ...