The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up plans to speed up the drug regulation process.

China's FDA is proposing new policies to hasten clinical trial approval and lift restrictions placed on trial sites.

China's FDA and Supreme Court, in a seemingly synchronized move, are proposing new actions against forging clinical trial data, and criminal charges are…

Texas-based Moleculin Biotech penned a deal with Theradex Systems to help it run early-stage trials for its candidate annamycin in acute myeloid leukemia.

The European Medicines Agency wants to suspend around 300 marketed generic meds and applications due to its concerns.

Charles River Laboratories has agreed to pay the U.S. government $1.8 million to settle allegations that it overbilled the NIH for contract services it didn’t…

The U.S. FDA selects Icon to validate three patient-reported outcome (PRO) instruments used to assess clinical endpoints in antibacterial drug trials.

A recent study by German researchers found that postmarketing trials funded by the industry are not effective in identifying safety issues.

Regulatory