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 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 ...

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

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 ...

The results of the study, dubbed MAPP2, will support the submission of a new drug approval application expected from MAPS PBC in the third quarter of 2023. “The Phase 3 confirmatory results ...

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