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Complete Response Letter
Pharma
FDA rejects Abeona' Therapeutics' topical gene therapy pz-cel
The FDA has rejected Abeona Therapeutics' gene therapy pz-cel, specifying chemistry, manufacturing and controls (CMC) issues that must be addressed.
Kevin Dunleavy
Apr 23, 2024 11:16am
FDA again rejects Supernus' Parkinson's disease pump
Apr 8, 2024 10:15am
Viatris, Mapi's long-acting MS drug rebuffed by FDA
Mar 11, 2024 11:11am
FDA says yes to Allecra's antibiotic combo after CRL for another
Feb 27, 2024 11:44am
Venatorx, Melinta's antibiotic rejected over manufacturing issues
Feb 23, 2024 10:55am
FDA rejects Satsuma's migraine spray over manufacturing concerns
Jan 18, 2024 11:18am