The Food and Drug Administration in recent months has approved a small number of drugs quite quickly under a new expedited ...
FDA official: 17 drugs approved using continuous manufacturing, growth seen in emerging tech program
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) ...
As the Trump administration begins to make its mark on the Medicare drug price negotiation program, litigation over the program continues. In the two years since the first case challenging the program ...
Many of the directions included in the order will be familiar to those who watched drug pricing policy closely during the first Trump Administration, though the portions of the order relating to the ...
Eligible patients in the expanded access program will be able to receive daraxonrasib from their healthcare provider.
Sanofi has asked the U.S. Food and Drug Administration to pull its diabetes drug out of the regulator's new fast-track review program, STAT News reported on Wednesday.
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