Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration may not seek its outside experts' advice when ...

The US FDA has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid.

The US Food and Drug Administration (FDA) has approved lenacapavir, an injectable drug that offers long-lasting protection ...

Research finds widespread synthetic dye use in US packaged foods and drinks as FDA pushes phase-out amid rising child health ...

A federal judge has rejected a bid by compounding pharmacies to allow them to continue making copies of Novo Nordisk's ...

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug ...

Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application for prucalopride ...

Clinical trials showed 99.9% of participants who received the drug, called Yeztugo​ from company Gilead Sciences, remained ...

The US Food and Drug Administration announced a new national priority voucher plan that aims to cut drug review times to one ...

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

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