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

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

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

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 ...

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 ...

Mural nominated two new development candidates, MURA-8518 a novel binding protein-resistant IL-18 with half-life extension, ...

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