Two government officials told STAT that the White House has been involved in final decisions about the FDA's new priority ...
The U.S. Food and Drug Administration approved on Tuesday the first drug under its new fast-track program designed to shorten review time for a drug application.
The FDA awarded two national priority review vouchers through its Commissioner's National Priority Voucher pilot program on Dec. 19, bringing the ...
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...
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Exclusive: US FDA taps Merck drugs with blockbuster sales potential for national priority vouchers
The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with ...
The FDA taps J&J drug teclistamab for its National Priority Voucher pilot, enabling expedited review for multiple myeloma treatment.
FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File) WASHINGTON (AP) — The Food and ...
Companies can ask the FDA to waive premarket authorization and investigational device requirements while they collect ...
FDA plans to fast-track reviews of two experimental Merck drugs under its priority voucher program, potentially accelerating ...
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 ...
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