Category - New Drug Applications
Merus Receives FDA Extension of PDUFA for Zenocutuzumab
Ionis Announces FDA Acceptance of New Drug Application for Donidalorsen for Prophylactic Treatment of HAE
Dizal Submits New Drug Application to the U.S. FDA for Sunvozertinib in Treating Relapsed or Refractory Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Neurotech Provides Update on BLA for NT-501 as a Treatment for Macular Telangiectasia Type 2 (MacTel)
Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis
Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease
Abeona Therapeutics Announces FDA Acceptance of BLA Resubmission of Pz-cel for the Treatment of Recessive Dystrophic Epidermolysis Bullosa
Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the US for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer