The FDA cleared the investigational new drug application for REC-4539, allowing for the start of a phase 1/2 trial in small ...

The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...

Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.

The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...

The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell ...

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its ...

Corcept Therapeutics submitted a new drug application to the Food and Drug Administration for its treatment of hypercortisolism, or Cushing's syndrome, a hormonal disorder that occurs when the body ...

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, ...

On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded ...

Corcept Therapeutics (CORT) has submitted a new drug application to the FDA for its proprietary, selective cortisol modulator, relacorilant, to ...

has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous hypercortisolism ...