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

Vanda (VNDA) has written a letter to FDA Commissioner Robert Califf asserting that the review of the market application for ...

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 ...

Revidia Therapeutics Inc., a cardiac regenerative medicine company developing first-in-class small molecule drug therapies for heart injury, has announced that it has expanded its leadership team in ...

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

Chimerix submitted a new drug application to the FDA seeking accelerated approval for dordaviprone to treat patients with ...

A new drug application seeking the accelerated approval of dordaviprone forrecurrent for H3K27M-mutant diffuse glioma ...

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

Innovent Biologics, Inc., a world-class biopharmaceutical company that develops, manufactures and commercializes high quality ...

The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...