FDA Drug Approval Decisions Expected in October 2024 - MPR - eMPR.com

September 6, 2024

Dasiglucagon for congenital hyperinsulinism has a PDUFA date of October 8, 2024, supported by phase 3 trials. Perioperative nivolumab-based regimen for resectable NSCLC also has a PDUFA date of October 8, 2024, based on the CheckMate -77T trial. Oclaiz (CAM2029) for acromegaly has a PDUFA date of October 21, 2024, supported by phase 3 studies. Sulopenem etzadroxil/probenecid for uncomplicated UTI has a PDUFA date of October 25, 2024, with data from the REASSURE trial.

Related Clinical Trials

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer

Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

A Trial to Assess the Long-term Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon in Children With Congenital Hyperinsulinism

A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With Acromegaly

Reference News

empr.com

FDA Drug Approval Decisions Expected in October 2024 - MPR - eMPR.com