Category - New Drug Applications
Abeona Therapeutics Provides Regulatory Update on Pz-cel
Milestone Pharmaceuticals Announces FDA Acceptance of New Drug Application for Cardamyst
FDA Grants Priority Review to Roche’s Inavolisib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer with a PIK3CA Mutation
Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA
AbbVie Provides U.S. Regulatory Update on ABBV-951 (Foscarbidopa/Foslevodopa)
Lexicon Pharmaceuticals Resubmits Sotagliflozin NDA for Type 1 Diabetes
KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-Demand Treatment for Hereditary Angioedema
Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections