A UroGen Pharma Ltd. investor has dropped his suit against the drug developer after the FDA approved the company’s new ...

The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently ...

The FDA has launched a pilot program using generative AI to help expedite the review of drug and device applications, part of a sweeping modernization effort by the agency. The initiative, led by FDA ...

UroGen Pharma shares surged after the company received Food and Drug Administration approval for bladder cancer drug Zusduri, previously known as UGN-102. The stock was recently up 36% to $9.96. Prior ...

There are problems with generative AI, and there need to be guardrails and there needs to be human oversight," said Jason ...

Artificial intelligence is beginning to reshape how drug companies interact with the Food and Drug Administration, though most changes so far have been limited.

FDA staffers in the Center for Devices and Radiological Health told NBC News that their AI pilot, CDRH-GPT, is buggy, isn't connected to the Internet or the FDA's internal system, and has problems ...

The U.S. Food and Drug Administration said on Monday that it had launched a generative AI tool, Elsa, aimed at improving ...

Food and Drug Administration Commissioner Marty Makary said he plans to review the safety of abortion drug mifepristone after ...