Exclusive: FDA staff struggle to meet product review deadlines after DOGE layoffs
Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...
DBV reports VITESSE trial sufficient to support BLA, discontinues COMFORT trial
DBV Technologies (DBVT) announced that in a written responses only to the company’s Type D IND meeting request, the FDA agreed with the ...
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After canceling meeting of independent advisers, FDA issues 2025-26 flu vaccine recommendations
they must contain strains that are officially selected by the FDA. That decision typically comes after a meeting of the World Health Organization’s Global Influenza Surveillance and Response ...
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Adial Pharmaceuticals Receives Positive Response from FDA Meeting Regarding Proposed In Vitro Bridging Strategy for AD04
In response, the FDA agreed with Adial’s proposed 505(b ... Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly ...