The revision of labeling for products approved or submitted for approval under an abbreviated new drug application (ANDA) depends on the labeling of the listed drug referenced in the ANDA.

Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.

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 ...

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 ...

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 ...

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 ...

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 ...

The spike followed news that the U.S. Food and Drug Administration (FDA) had accepted the company’s New Drug Application (NDA ... expediting the review process due to its potential to address ...

for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who ...