The FDA’s decision shines a light on some of the unique obstacles that psychedelic drugs may face on the path to approval. The pharma industry claims lower prescription drug prices will mean ...

The FDA’s decision shines a light on some of the unique obstacles that psychedelic drugs may face on the path to approval. The pharma industry claims lower prescription drug prices will mean ...

Vertex Pharmaceuticals’ suzetrigine, previously named VX-548, is steadily advancing along its rolling submission approval pathway okayed by the US Food and Drug Administration (FDA) for moderate ...

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

The integration of AI into drug submission and approval processes signifies a shift towards more efficient pharmaceutical development. The potential benefits are substantial, including faster ...

Ramaswamy said the case is less about abortion and more about administrative law and the FDA approval process, arguing the agency exceeded its authority by approving mifepristone in 2000.

Alzheimer’s disease robs patients of so much more than their health. It can rewire their personalities and undermine a ...

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

So for the FDA, the time of approval as the endpoint for market authorization is appropriate. In Europe, the EMA's process involves one more step, creating an intermediate time point that seems to ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

As long as social conservatives remain in power, review and approval process at the FDA will continue to come under heavy partisan scrutiny. Allowing decisions about medical science to be delayed ...

Geroscience has a long way to go, but there are four FDA-approved drugs that have shown promise to “target the process of ...