The National Cancer Institute’s Investigational New Drug program facilitates collaboration, not collusion, with industry for ...

AXS-12, known as reboxetine back when it was available as an antidepressant in the United States, may decrease cataplexy ...

The FDA has announced plans to phase out animal testing in the development of monoclonal antibodies and other drugs.

The initiative, which will start with monoclonal antibodies, is the first big regulatory shift from the FDA since Martin ...

The FDA will begin replacing animal testing in the development of monoclonal antibody therapies and other drugs with ...

The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab ...

In a landmark decision poised to revolutionize drug development, the U.S. Food and Drug Administration (FDA) has announced a ...

AI-driven drug discovery firms rallied on Friday after the U.S. Food and Drug Administration (FDA) announced an initiative to ...

The good news is that Investigational New Drug submissions and New Drug Applications continue to be above average, with the latter hitting a high not seen since 1999.

permit may be required and/or import may be prohibited unless there is an active Investigational New Drug (IND) application. If the product has been coated, there may be issues with countries ...

The MFDS (Ministry of Food and Drug Safety) offers a pre-investigational new drug (IND) submission consultation, which is advised prior to making the IND submission. There is no expiry date for ...