Fierce Biotech

Corcept submitted lead asset for approval despite FDA flagging risk of ‘significant review issues’

The FDA warned Corcept Therapeutics that it would face significant hurdles if it submitted its lead rare disease asset for ...
Parade on MSN

FDA Recall: Check for Contaminated Foods and Products from Gold Star Distribution

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

FDA Accepts BLA for Ivonescimab in Pretreated EGFR-Mutated NSCLC

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

Summit’s Potential Keytruda Rival Gets November FDA Decision Date

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.

FDA Decision on Eli Lilly's Weight Loss Pill Delayed to Q2. Is This Bad News for the Stock?

The target action date for orforglipron is now April 10.
Healio

FDA approves updated label with new dosing guidance for inhaled insulin

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

FDA Halts Two Gene Therapy Trials After Child Develops Brain Tumor

Studies of Hunter and Hurler syndromes on hold ...
CURE

FDA Accepts Ivonescimab Application for EGFR Lung Cancer

The FDA accepted an application for ivonescimab with chemotherapy for patients with lung cancer driven by EGFR changes after ...
Healio

FDA clears investigational new drug application for ER-100

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

FDA Approves First Dual-Agent Eye Drop for Presbyopia

The FDA has approved the first dual-agent eye drop to treat presbyopia, a condition that causes gradual loss of near vision in adults.
MedPage Today on MSN

FDA OKs More Eye Drops That Can Replace Reading Glasses

Once-daily carbachol/brimonidine tartrate significantly improves aging-related vision loss ...
Lupus Foundation of America

Biogen’s litifilimab receives FDA Breakthrough Therapy Designation to further develop treatment for cutaneous lupus erythematosus

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).