The FDA issued a complete response letter for the resubmission of the reproxalap new drug application for the treatment of ...

The FDA is moving away from requiring animal models for investigational new drug (IND) applications for new monoclonal ...

FDA has cleared an investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient ...

The company stated that the FDA noted at least one additional adequate and well controlled study to demonstrate a positive ...

Ziftomenib has received Breakthrough Therapy, Fast Track, and Orphan Drug Designations. The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review; Kura ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

The FDA granted a positive review for an acute myeloid leukemia drug trial, with initial dosing expected in 2025.

The U.S. Food and Drug Administration said on Thursday it plans to replace animal testing in the development of monoclonal ...

today announced that its supplemental new drug application (sNDA) of Gvoke VialDx™ has received U.S Food and Drug Administration (FDA) approval for use as a diagnostic aid during radiologic ...

Sun Pharma Advanced Research Company (SPARC) said that it has submitted an investigational new drug (IND) application with the US Food and Drug Administration (FDA) for its antibody-drug conjugate ...