Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, in combination with enzalutamide in patients with me ...

A new drug application is planned for early 2025 for the indications of schizophrenia and bipolar I disorder for milsaperidone after a successful pre-NDA meeting with the FDA earlier this year.

Arkansas researchers are testing a product commonly used to treat ticks and fleas on pets to target fly and mosquito larvae ...

(AskBio), a gene therapy company wholly owned and independently operated as a subsidiary of Bayer AG, today announced that AB-1003 (also known as LION-101) has received rare pediatric disease ...

Arkansas researchers are testing a product commonly used to treat ticks and fleas on pets to target fly and mosquito larvae ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 (“GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

The US FDA has cleared an investigational new drug (IND) application for HG202, by HuidaGene Therapeutics. This drug is the ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...

MANILA, Philippines — A task force to investigate the killings during the war on drugs of former President Rodrigo Duterte has been formed by the Department of Justice. The task force has been ...

This drug is the world’s first-ever CRISPR/Cas13 RNA-editing therapy for clinical use in treating neovascular age-related macular degeneration (nAMD). The US FDA has cleared an investigational new ...

While A.I. promises breakthroughs, industry leaders warn that transparency and patient safety must remain front and center.