Accelerated approval can serve patients well—but only when surrogate endpoints are reliable and clearly predict outcomes that matter to patients.

Scientists have made a breakthrough in understanding how Alzheimer’s disease develops, and a decades-old drug could be the ...

What Is Uplizna, and Why Does It Matter? Uplizna (inebilizumab-cdon) is a prescription medicine recently approved by the FDA to treat adults with generalized myasthenia gravis (gMG) who test positive ...

BridgeBio is hoping infigratinib will get another shot at approval after the medicine hit the key goals of a phase 3 study in ...

Add Yahoo as a preferred source to see more of our stories on Google. The FDA has approved a new pill version of the weight-loss drug Wegovy - Novo Nordisk The US Food and Drug Administration on ...

Former FDA Commissioner Dr. Scott Gottlieb joins 'Squawk Box' to discuss the fight between Novo Nordisk and Hims & Hers over ...

WASHINGTON (AP) — The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the ...

A Las Vegas-based biotech CEO has a vision of Nevada as a hub for medical innovation, and he is hoping voters will help him make it happen.

The US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes ...

Feb 13 (Reuters) - Disc Medicine said on Friday the U.S. Food and Drug Administration has declined to approve its drug to treat a rare genetic disorder, sending its shares down more than 20% by the ...