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 ...

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 ...

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

A surge of generics, biosimilars, and innovative therapies is expected in 2025, addressing conditions from cancer to chronic ...

Grace Therapeutics (GRCE) announced details of the Company’s Type C meeting with the U.S. Food and Drug Administration. The purpose of this ...

The US Food and Drug Administration (FDA) has granted clearance to CureVac's investigational new drug application (IND) for ...