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 ...

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early ... needed for the IRB and/or FDA to make a determination. Learn more on the FDA process Here is where differences ...

Breakthrough Therapy Designation: a process that speeds up the development and review ... a patient responds to treatment without their cancer growing or spreading. New Drug Application (NDA): a ...

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 ...

The trial outcomes are expected to be pivotal for regulatory submissions in the future, including the FDA505(b)(2) new drug application process. Prior to this, Incannex conducted a Phase I trial ...

Corcept Therapeutics Incorporated CORT recently announced the submission of a new drug application (NDA) to the FDA for its proprietary, selective cortisol modulator, relacorilant, to treat ...

has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for its proprietary, selective cortisol modulator, relacorilant, to treat patients with endogenous ...

Agencies such as the FDA and EMA are involved in the regulatory process and there are some specific applications new drug sponsors need to file for regulatory approval. The Investigational New ...

Corcept Therapeutics submitted a new drug application to the Food and Drug Administration for its treatment of hypercortisolism, or Cushing's syndrome, a hormonal disorder that occurs when the ...