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 ...

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

Astellas Pharma Inc. (ALPMY, ALPMY) announced that the U.S. Food and Drug Administration accepted the revised supplemental New Drug ...

Investigational new drug (IND) applications for initiating first-in-human studies for ZW220 and ZW251 in solid tumors anticipated in 2025IND applications for initiating first-in-human studies for ZW20 ...

Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) letter to FDA Commissioner highlights faulty gastroparesis NDA review. As ...

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 ...

Chairman of the Board, Wei Fu, informed the Company of his intent to purchase up to $2,000,000 of the Company's American ...

Solid Biosciences Inc. SLDB announced that the FDA has cleared its investigational new drug (IND) application to begin ...

Dr. Anil Diwan, President of NanoViricides, Inc. (NYSE American: NNVC) (the “Company”), comments on the many viruses that could cause pandemics that are going around already.

Variant Bio, a small biotech company based in Seattle, is using genetic information from Indigenous people to develop drugs for obesity and diabetes.