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 ...

Yuhan Corp. posted record-breaking third-quarter results, with revenue reaching 598.8 billion won and operating profit ...

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 ...

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.

Si-Bone Inc. ’s fourth quarter (Nasdaq: SIBN) got off to a good start in October after the U.S. Food and Drug Administration ...

SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...

Below, I'll break down what's going on at Viking and explain how the company may emerge as a competitive force in the weight ...

The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...