The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

A new weekly injectable drug could transform the lives of more than eight million people living with Parkinson's disease, ...

"EQUIP-A-Pharma is about point-of-need manufacturing—hospitals, military bases, disaster zones—ensuring rapid drug ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA has updated the labeling for Kisunla™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer disease.

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...