A recent FDA Warning Letter signals a broader regulatory focus on how drugmakers use artificial intelligence, according to a new analysis by law firm ...
FDA issues AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthe...
FDA sends an untitled letter to Incyte Corp., warning that portions of the companys consumer-facing Web site for Niktimvo (axatilimab-csfr) contain fa...
FDA releases a form FDA-483 with six observations from an inspection at Indias Global Calcium active pharmaceutical ingredient manufacturing facility....
Consumers for Dental Choice and two other advocacy groups again petition FDA to ban the use of mercury amalgams in dentistry, especially for vulnerabl...
FDA approves a Regeneron Pharmaceuticals BLA for Otarmeni (lunsotogene parvec-cwha), the first gene therapy for a form of inherited hearing loss.
FDA commissioner Marty Makary says the agency is not planning to eliminate direct-to-consumer pharmaceutical advertising, even as it ramps up enforcem...
FDA issues an early alert warning healthcare providers about a potentially dangerous defect in certain angiographic syringes included in medical conve...
