Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its ...
The FDA is putting Atara’s active Investigational New Drug applications on hold due to manufacturing concerns at a ...
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...
The US Food and Drug Administration (FDA)’s recently issued final rule establishing application, labeling, and postmarketing reporting ...
Korea accelerates drug approvals by requiring 180-day advance supply suspension notice Korea reforms its drug approval ...
Researchers at Leipzig University have developed a new process for reversing the polarity of chemical compounds, also known as umpolung, for the precise synthesis of pharmaceuticals. This innovative ...
FDA denies Vanda's Tradipitant application for gastroparesis, urging new trials for efficacy and safety. Vanda disputes the ...
The FDA has approved the investigational new drug application of 225Ac-SSO110, allowing for the start of a phase 1/2 trial in ...
Scientists have taken a major step forwards in tackling one of the greatest abiding challenges in chemistry, by learning how to program the self-assembly of molecules in such a way that the end result ...
We recently published a list of Billionaire Joseph Edelman’s Top 10 Long-Term Stock Picks. In this article, we are going to ...