ALX Oncology: Evorpacept Receives ODD to Treat GC
The U.S. Food and Drug Administration (FDA) has granted an orphan drug designation (ODD) for ALX Oncology’s evorpacept, a next-generation CD47 blocker, to treat patients with gastric cancer and gastroesophageal junction cancer. Gastric cancer and gastroesophageal...
Imara IND Clearance: Tovinontrine (IMR-687) to Treat HFpEF
The U.S. Food and Drug Administration (FDA) has cleared Imara’s Investigational New Drug (IND) application for tovinontrine (IMR-687) to treat heart failure with preserved ejection faction (HFpEF). HFpEF (diastolic heart failure) is a form of heart failure that occurs...
VYVGART: Approval for Treatment of Myasthenia Gravis
Japan’s Ministry of Health, Labour, and Welfare (MHLW) has approved agrenx SE’s VYVGART (efgartigimod alfa) intravenous infusion for the treatment of generalized myasthenia gravis (gMG) in adult patients who did not see improvements from pervious treatment with...
Investigational New Drug: CX-904 To Treat Solid Tumors
The U.S. Food and Drug Administration (FDA) has granted clearance of CytomX and Amgen’s Investigational New Drug Application (IND) for CX-904, a T-cell-engaging bispecific antibody, to treat advanced solid tumors. Solid tumors can be malignant or benign, typically...
Diadem’s AlzoSure Predict: Breakthrough Device Designation
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...
FDA IND Clearance: Topical Agent to Treat Dry Eye Disease
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...
FDA IND Approval: SNIPR001 to Target E. coli Infections
SNIPR BIOME has announced the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug (IND) application for SNIPR001 to target E. coli infections in cancer patients. E. coli bacteria live in the intestines of healthy people and while most...
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