Attorneys said many questions remain about LDT regulation after the FDA lost its legal fight. A recent warning letter could ...

KalVista Pharmaceuticals' said on Friday that the U.S. Food and Drug Administration had extended the review of its drug for a ...

While some compounding pharmacies have stopped making alternatives to Wegovy and Zepbound since shortages were declared over, ...

Ocugen has announced the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) amendment to ...

One of India's largest drugmaker shares slipped on Monday, June 16, after the US Food and Drug Administration (US FDA) issued ...

Leaders of the FDA have published a list of new priorities for the agency. They want to deliver rapidly-approved cures and ...

Texas has moved to fund research into ibogaine, a psychedelic drug that may help treat addiction, depression and brain ...

Rein Therapeutics has paused patient enrollment and dosing in a mid-stage trial of its lung disease drug in the U.S. after ...

The FDA plans to "unleash AI" on new drug evaluations in order to "radically increase efficiency in the review process." ...