Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Empower Pharmacy, a Houston-based compounding pharmacy, has been sanctioned by the FDA and other states in the past decade.

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

For consumers, the FDA and Upper Crust Bakery LP advised that bread with affected lot numbers should not be consumed but ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

Sarepta Therapeutics (SRPT) stock drops as the company faces potential FDA-mandated studies after safety concerns over its ...

With reports that FDA’s AI Elsa is “confidently hallucinating” studies that don’t exist, the use of AI to streamline drug ...

By Kingsley Webora TANKEH Bureaucratic bottlenecks and high regulatory costs at the Food and Drugs Authority (FDA) are discouraging many small- and medium-sized enterprises (SMEs) from obtaining the ...

Despite ambitions to streamline regulatory review, FDA’s Elsa platform has been prone to hallucinations, prompting internal scrutiny and questions about AI reliability and governance.