The FDA agreed to review Moderna's mRNA-based flu vaccine after initially rejecting the application, following a Type A meeting that led to a revised regulatory approach splitting approval pathways by age group.
The FDA reversed its initial rejection and will now review Moderna's mRNA-based flu vaccine application after the company proposed a revised regulatory approach, targeting approval by August 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07565090 |
A Clinical Study to Investigate the Safety and Immunogenicity of rVSV∆G-SUDV-GP, a Sudan Virus (SUDV) Vaccine for the Prevention of SUDV Disease in Adults in Good General Health |
NOT_YET_RECRUITING | PHASE1 |
| NCT07425821 |
A Phase 1 Randomized, Observer-blind, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-MARV-GP Vaccine in Adults in Good General Health |
RECRUITING | PHASE1 |
| NCT07379684 |
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic Wound Infections |
RECRUITING | PHASE1 |
| NCT07217886 |
A Study of S-892216-PO in Participants With Renal Impairment and Matched Controls |
RECRUITING | PHASE1 |
| NCT07128615 |
A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA) |
ACTIVE_NOT_RECRUITING | PHASE1/PHASE2 |
| NCT07104162 |
A Study to Investigate Safety and Pharmacokinetics of Intravenous Cefiderocol/Xeruborbactam in Participants With Renal Impairment |
RECRUITING | PHASE1 |
| NCT07035769 |
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults |
RECRUITING | PHASE1 |
| NCT06961708 |
A Study of Fosmanogepix in Healthy Adult Chinese Subjects |
COMPLETED | PHASE1 |
| NCT06938867 |
Phase 1b/2a Randomized Double-blind Study to Investigate Safety Tolerability PK PD Preliminary Efficacy of Oral Administration of SNIPR001 in Patients With Hematologic Malignancy Scheduled for Allogeneic Hematopoietic Stem-Cell Transplant Receiving FQ Prophylaxis & Harboring FQR Ecoli Pre-Transplant |
RECRUITING | PHASE1/PHASE2 |
| NCT06925321 |
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections. |
RECRUITING | PHASE3 |
