But three of those FDA employees told CNN that Elsa just makes up nonexistent studies, something commonly referred to in AI ...

The European Union has approved GSK's drug Blenrep to treat relapsed or treatment-resistant forms of a cancer affecting blood ...

The U.S. Food and Drug Administration has extended its review of GSK's blood cancer drug, Blenrep, as a combination treatment ...

Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s ...

The U.S. Food and Drug Administration ( FDA) has placed an immediate clinical hold on Sarepta Therapeutics' investigational ...

The Food and Drug Administration has granted permission for Juul to continue selling its e-cigarettes, offering some reprieve ...

Tidmarsh, who has founded and served as CEO of several biotech companies, will lead a crucial FDA division that reviews the ...

The FDA recently unveiled a new national priority voucher program that would seek to trade faster drug approvals for lower ...

Unpredictable FDA and funding woes delay crucial drug approvals, depriving thousands of patients access to vital treatments ...

The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and ...

GoodRx reports that in 2025, novel drug and biosimilar approvals lag slightly behind last year, while first generic approvals ...

Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...