Importantly, no serious safety concerns were reported in PATHFINDER 2. Detailed PATHFINDER 2 data are expected to be ...

Many FDA accelerated approvals continue to rely heavily on surrogate endpoints, raising ongoing uncertainty about the true clinical benefits of these therapies.

If you’ve been taking Ozempic or Wegovy (both of which contain the active ingredient semaglutide), you might wonder, How long ...

The FDA said there were approximately 883 loaves of bread that contained visible hazelnuts. Hartford Bakery has removed all ...

The U.S. Food and Drug Administration (FDA) recently announced a new Commissioner’s National Priority Voucher (CNPV) program, ...

The Food and Drug Administration said Monday it has granted approval of a new blue food coloring produced from the gardenia fruit, while urging food manufacturers to quickly abandon a synthetic ...

A New Jersey-based company is recalling its 200-gram packages of needle mushrooms because they may be contaminated with listeria.

The U.S. Food and Drug Administration (FDA) has announced a recall of a select lot of Boar’s Head deli products due to a labeling error. Sixty-five cases, amounting to 780 packages, of Boar’s Head ...

Gayheart Mensah is new Acting Deputy Chief Executive Officer in charge of the Corporate Services Division at FDA ...

Investigation Reveals Deep Flaws in FDA Drug Approval Process, Raising Concerns Over Public Safety** A recent investigative report has uncovered alarming findings regarding the ...

The manufacturing-related rejection for UX111 is more than a setback for Ultragenyx, as it also delays a key test of the new ...

The FDA action comes weeks after US Health Secretary Robert F. Kennedy Jr said the government would no longer recommend the COVID vaccine for healthy children or pregnant people.