Their results argue for a change to parity between small-molecule agents and biologics when it comes to Inflation Reduction ...

Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...

In a groundbreaking study, researchers at McMaster University have identified a potential treatment for Sandhoff and Tay-Sachs diseases—two rare, often fatal lysosomal storage disorders that cause ...

Donald Trump's Agenda 47 and the Heritage Foundation's Project 2025 provide plenty of clues into what health-care changes may ...

People suffering from major depressive disorder (MDD) and treatment-resistant depression (TRD) often face challenging ...

Ku says that Kennedy could have some influence around vaccines if he was in charge of the FDA, which approves vaccines, or ...

The blockbuster drugs Ozempic and Wegovy may help people cut back on drinking, new research published Wednesday in JAMA ...

PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...

A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous ...

LOUISVILLE, Ky. -- More than half of patients with newly diagnosed metastatic kidney cancer responded to a novel drug ...

Ronholm’s concern isn’t just with Red No. 3. He said several FDA-approved synthetic dyes have been linked in studies to ...

The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.