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

The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.

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, ...

Absci will use AMD’s $20 million investment to enhance its AI models. In parallel, the companies will collaborate to develop ...

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 ...