FDA submission
Atamyo Therapeutics Files IND to Begin Testing Limb-Girdle Muscular Dystrophy Gene Therapy in US
The clinical trial testing ATA-200 to treat a type of LGMD caused by mutations in the SGCG gene has already been cleared in Italy and France.
Fujirebio Files Blood-Based Alzheimer's Test With FDA
The test measures levels of p-tau 217 and β-Amyloid 1-42 in human plasma to identify patients with the amyloid brain pathology characteristic of Alzheimer's disease.
Atara Biotherapeutics Seeking Approval for T-Cell Immunotherapy Tabelecleucel in US
The FDA is expected to decide whether to approve tabelecleucel as a treatment for EBV-positive post-transplant lymphoproliferative disease by Jan. 15, 2025.
Astellas Resubmits BLA to FDA for Zolbetuximab in CLDN18.2-Positive Gastric Cancer
The FDA had issued a complete response letter for the initial BLA seeking approval for zolbetuximab due to manufacturing concerns.
Jazz Pharma Seeking Approval for Zanidatamab in HER2-Positive Biliary Tract Cancer
The application was based on Phase IIb trial results showing a 41 percent response rate on zanidatamab in this setting.