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Complete Response Letter
Pharma
FDA rejects Elevar, Hengrui's PD-1 combo
Elevar and Hengrui's camrelizumab continues the struggle China-made PD-1s have experienced with the FDA.
Angus Liu
May 17, 2024 10:16am
Ascendis must wait 3 more months for FDA verdict on TransCon PTH
May 14, 2024 5:36pm
FDA rejects Abeona' Therapeutics' topical gene therapy pz-cel
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