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 ...

Exelixis said it was notified by the Food and Drug Administration that its treatment for advanced pancreatic neuroendocrine tumors and advanced extra-pancreatic will not be discussed at a meeting.

Loteprednol Etabonate Ophthalmic Gel, 0.38% (RLD Lotemax SM) had an estimated annual sale of USD 36 million in the U.S.

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 ...

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

The Phase III trial successfully saw patients achieving clinical remission and stopping rectal bleeding within 28 days.

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

Agios Pharmaceuticals AGIO announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label ...

Shares of Catalyst Pharmaceuticals CPRX gained 16.7% on Wednesday after the company, along with its licensor, SERB, announced ...