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

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 ...

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

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

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

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 ...

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

This NDA submission marks a pivotal moment for Chimerix in our mission to bring this potentially life-altering drug to patients diagnosed with recurrent H3 K27M-mutant diffuse glioma,” said Mike ...