The FDA warned Corcept Therapeutics that it would face significant hurdles if it submitted its lead rare disease asset for ...
A massive multi-category product recall has been issued after a pest infestation discovery.
The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...
Ivonescimab's BLA acceptance is a milestone for PD-1/VEGF bispecific antibodies in the U.S., potentially transforming ...
The FDA is currently reviewing Summit's PD-1/VEGF bispecific as part of a chemotherapy combo for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer.
Life Biosciences plans to begin human clinical trials of a cellular rejuvenation therapy in optic neuropathies after ...
The target action date for orforglipron is now April 10.
For companies developing digital health products, wearables, or software-enabled devices, FDA’s latest guidance updates ...
By Kamal Choudhury Jan 30 (Reuters) - Shares of Corcept Therapeutics fell 16% on Friday after a corrected "complete response letter" from the U.S. Food and Drug Administration showed the agency had ...
Once-daily carbachol/brimonidine tartrate significantly improves aging-related vision loss ...
The U.S. Food and Drug Administration (FDA) has granted Biogen’s investigational drug, litifilimab, Breakthrough Therapy Designation for the treatment of cutaneous lupus erythematosus (CLE).