New diagnostic kits aim to revolutionize early screening of the disease, potentially allowing patients to receive treatments—such as monoclonal antibodies—sooner.

Developers of biosimilars will no longer be required to conduct clinical trials to prove effectiveness for FDA approval.

Ironically enough, his initial downfall had nothing to do with Daraprim. Soon after he became infamous, federal prosecutors ...

Unregulated compounded GLP-1s are not the same as the legitimate medications that doctors prescribe for weight loss and chronic disease management.

The U.S. FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, ...

The FDA has approved Transcranial Magnetic Stimulation (TMS), a non-drug, magnetic pulse device, for use in teens as young as 15 to treat severe depression.

The FDA approved darolutamide for mHSPC on June 3, [2025], so we now have this in our armamentarium, along with all the other ...

The FDA approved an intravenous (IV) formulation of fosfomycin (Contepo) to treat adults with complicated urinary tract ...

The latest turmoil within Commissioner Marty Makary’s Food and Drug Administration, an alleged bribery scandal involving a high-level official, is no anomaly. The Sunday resignation of the Center for ...

A biotech stock with strong FDA approval odds this November may see limited upside amid a full valuation and a pending lawsuit.

An alleged extortion attempt, a petty yearslong grudge, shocking social media posts, and ominous text messages make up the ...