Senhwa Biosciences’ Pidnarulex (CX-5461) has been granted a Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of solid tumors with BRCA1/2, PALB2, and other gene mutations. In patients with solid tumors, specifically breast...
In regulatory news today, the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application from Applied Pharmaceutical Science for its breakthrough drug, APS03118, to target multiple advanced cancer types. APS03118 has...
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for Arch Oncology’s next-generation anti-CD47 IgG2 antibody, AO-176, for the treatment of relapsed/refractory multiple myeloma (r/r MM). Multiple myeloma is a cancer of mature plasma...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Diadem’s AlzoSure Predict, a blood-based biomarker prognostic assay designed to identify early signs of Alzheimer’s disease and determine the potential rate of progression in...
The U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Aramis Biosciences’ immunomodulatory agent, A197, for the treatment of dry eye disease. Dry eye disease is a common, chronic, immune-mediated disease that is...
The U.S. Food and Drug Administration (FDA) has granted both a Fast Track Designation and a Regenerative Medicine Advanced Therapy Designation (RMAT) to Cellular Biomedicine’s (CBMG) autologous b-specific therapy, C-CAR039, for the treatment of patients with diffuse...
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