Following the clearance of an investigational new drug application from the FDA, a phase 1 trial will examine the novel ...

Unicycive, which is seeking an FDA green light for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease who are on dialysis, Monday said the agency set a target ...

FDA sets PDUFA Action Date of June 28, 2025 ...

Dizal has submitted sunvozertinib’s new drug application (NDA) to the US Food and Drug Administration (FDA) aiming to secure approval for treating locally advanced or metastatic non-small cell lung ...

I have long held the belief that digital therapeutics will be prescribed alongside drugs to improve patient outcomes, leading ...

Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem ...

must submit an NDS within 12 months of filing a New Drug Application (NDA) in the US. This requirement is established by ...