The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

The Prescription Drug User Fee Act target action date for the NDA is scheduled for 24 July 2026.

FDA PreCheck pilot aims to speed U.S. pharma plant construction and approvals for critical medicines with earlier feedback.

Ivonescimab's BLA acceptance is a milestone for PD-1/VEGF bispecific antibodies in the U.S., potentially transforming ...

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, including two that would expand the labels of blockbuster drugs.

Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...

The U.S. Food and Drug Administration (FDA) is celebrating a historic milestone in 2026, marking 120 years of national ...

After finding an intraventricular tumor in one clinical trial participant, the FDA placed a clinical hold on an experimental ...

For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...

A massive multi-category product recall has been issued after a pest infestation discovery.