Capricor Therapeutics said on Tuesday the U.S. Food and Drug Administration has indicated that an advisory panel review may ...

The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...

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

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 ...

JB Chemicals has received US FDA approval to market its generic version of Amitriptyline Hydrochloride tablets, used to treat ...

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 ...

The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...

The top drug regulator at the Food and Drug Administration announced Wednesday that she’s retiring in July. Her departure is the latest in a series of top leaders leaving the FDA since President Trump ...

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