The FDA has accepted a new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian ...

Relacorilant is a selective glucocorticoid receptor antagonist that selectively binds to the GR, thereby modulating cortisol activity.

Corcept Therapeutics ( ($CORT) ) just unveiled an announcement. On September 10, 2025, Corcept Therapeutics announced that the FDA has accepted ...

Advisory committee meetings help FDA scientists make decisions and increase public understanding of drug regulation, and ...

The Prescription Drug User Fee Act (PDUFA) date refers to the deadline set by the US Food and Drug Administration (FDA) for reviewing a New Drug Application (NDA) or Biologics License Application (BLA ...

The FDA is moving to scale back its long-standing use of expert panels to review drug applications, KFF Health News reported Sept. 12. George Tidmarsh, MD, PhD, director of the FDA’s Center for Drug ...

Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT) is one of the 14 Best Small Cap Stocks to Buy Right Now. On September 3, Arcutis ...

With a flurry of recent Big Pharma investment in radiopharmaceutical therapeutics, the FDA issued draft guidance last month ...

The U.S. Food and Drug Administration (FDA) has approved the New Drug Application, or NDA, for Camcevi ETM (leuprolide mesylate 21 milligrams), a ready-to-use long-acting injectable (LAI) formulation ...

August 2025 marked a transformative month in oncology as the FDA accelerates approvals for innovative cancer therapies, enhancing treatment options for patients.