Following an inspection earlier this year that yielded a Form 483, Indian generics juggernaut Alembic Pharmaceuticals has ...

The FDA this month issued a warning letter to ImmunityBio regarding promotional statements about cancer drug Anktiva that the agency claims are “false or misleading.” The missive marks the first ...

While it is not uncommon for pharmaceutical and biotechnoogy companies to receive warnings letters from the FDA for various reasons, the issuing of around 100 letters recently could be the clearest ...

“A group of industry leaders warned on Tuesday that the artificial intelligence technology they were building might one day pose an existential threat to humanity and should be considered a societal ...

Zoll received a warning letter from the Food and Drug Administration citing quality concerns and problems with how the firm handles complaints. The warning letter focused on MRI compatibility problems ...

The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement activities. Some letters are not posted for public view until weeks or months after ...

Food and Drug Administration warning letters to food manufacturers, sellers and importers have been trending upward, and the shift is not incidental. It reflects a maturing regulatory environment ...

Olympus Medical Systems is once again receiving ire from FDA as the administration issued another warning letter to the manufacturer of endoscopes and endoscope accessories after inspecting an ...

CEO Arvind Krishna said in his letter to investors that IBM had underestimated the "magnitude" of clients changing spending ...

The FTC is warning of scammers attempting to convince targets that they've inherited a life insurance policy from a loved one ...