FDA approves 1st oral GLP1 drug Foundayo
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The FDA’s Commissioner’s National Priority Voucher program, unveiled in June 2025, is “shrouded in secrecy,” Democratic representative Jake Auchincloss said last month, as regulatory and biopharma leaders try to decode the criteria for investigational or approved drugs to receive a voucher.
Add Yahoo as a preferred source to see more of our stories on Google. Dr. Marty Makary, commissioner of the Food and Drug Administration, speaks in the Oval Office of the White House during an event with President Donald Trump, Thursday, Oct. 16, 2025, in ...
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Legal questions swirl around FDA's new expedited drug program, including who should sign off
WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries that the plan may run afoul of ...
Foundayo’s approval also makes history as the first new molecular entity (NME) approved under the National Priority Voucher Program. 4 Issued 50 days after filing and 294 days before the application’s PDUFA date of January 20, 2027, this approval also represents a historic milestone as the fastest approval of an NME since 2002. 4
Last year, state lawmakers set aside $50 million for research into the psychoactive drug, which can treat opioid withdrawal and other mental health conditions.
The Food and Drug Administration Monday announced an initiative to encourage the use of RFID by drug companies. Phillips Industries’ new Cincinnati-area distribution center is now shipping aftermarket trucking parts nationwide, aiming to speed up ...