An emerging biotech called ESSA Pharma Inc. (EPIX) is developing treatments for prostate cancer that is no longer responding to current therapies. The venture is developing a series of compounds (antigens) that disrupt the androgen receptor (AR) signaling pathway via...
IND
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TrialSite News Original Research: What is the Average Time from IND Approval to NDA Approval?
The TrialSite News research team recently conducted research to understand trends in drug development timelines—from initial Investigatory New Drug (IND) filling to New Drug Application (NDA) approval. We encountered some surprises. First, we found that that the FDA...
FDA Clears Mustang Bio’s IND for MB-102 (CD123-CAR T)
Mustang Bio, Inc (MBIO) reports that the U.S. Food and Drug Administration (FDA) has approved the Company’s investigational new dug application (IND) in acute myeloid leukemia (AML) blastic plasmacytoid dendritic cell neoplasm (BPDCN) and high-risk myelodysplastic...
Biohaven Announces Acceptance of Investigational New Drug IND Filing for Rimegepant in China
Rimegepant(NYSE: BHVN) is an investigational drug candidate for the treatment of migraine. Originally discovered by Bristol-Myers Squibb, it is currently under development by Biohaven. Based in New Haven, CT. Biohaven is a clinical-stage biopharmaceutical company,...
China-based I-Mab Receives FDA IND Approval for Anti-GM-CSF Monoclonal Antibody TJM2
I-Mab Biopharma is a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immune-oncology and autoimmune diseases. It recently announced its TJM2 humanized immunoglobulin G1 (IgG1) targeting...