The FDA clearance aids AstraZeneca and Daiichi Sankyo’s plan to position ADCs like Enhertu ahead of chemotherapy in a variety ...

The Food and Drug Administration approved Novo Nordisk’s Ozempic as the first GLP-1 treatment option for people with type 2 ...

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide) to reduce certain risks ...

Novo Nordisk said the Food and Drug Administration approved the diabetes-drug Ozempic to be used to help kidney-disease patients. Ozempic, or semaglutide, can now be used to reduce the risk of ...

Ozempic’s expanded approval in the U.S. could transform how doctors treat patients with the condition, which involves a ...

PDUFA date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT)- Commercial capabilities ...

PDUFA date of March 27, 2025 for CARDAMYST (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) - Commercial capabilities build out in process, with proposed launch in PSVT targe ...

The FDA approved a wide range of therapies in 2024, including many new molecular entities and biological products.

In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab ...

The results will support the company’s application for expanded labeling of its popular Farapulse pulsed field ablation system in a larger group of patients with atrial fibrillation.

The US Food and Drug Administration (FDA) has granted approval for Zydus Lifesciences to proceed with a randomised Phase IIb ...