Category - New Drug Applications
Aeglea BioTherapeutics Submits BLA to FDA for Pegzilarginase for the Treatment of Arginase 1 Deficiency
scPharmaceuticals Inc. Announces Resubmission of Furoscix New Drug Application
Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway
Hutchmed Receives Complete Response Letter from the U.S. FDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Coherus and Junshi Biosciences Receive Complete Response Letter from U.S. FDA for Toripalimab BLA
Axsome Therapeutics Receives FDA Complete Response Letter for New Drug Application for AXS-07 for the Acute Treatment of Migraine
Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark
Amryt Receives Complete Response Letter from the FDA for Oleogel-S10 NDA