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Moderna (MRNA) FDA Events

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FDA Events for Moderna (MRNA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Moderna (MRNA). Over the past two years, Moderna has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as COVID-19, mRNA-1010, mRNA-1018, mRNA-1083, mRNA-1283, mRNA-1287, and mRNA-1345. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Moderna's Drugs in FDA Review

COVID-19 vaccine - FDA Regulatory Timeline and Events

COVID-19 vaccine is a drug developed by Moderna for the following indication: Covid-19. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1010 - FDA Regulatory Timeline and Events

mRNA-1010 is a drug developed by Moderna for the following indication: Quadrivalent Seasonal Flu. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1018 - FDA Regulatory Timeline and Events

mRNA-1018 is a drug developed by Moderna for the following indication: pandemic influenza vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1083 - FDA Regulatory Timeline and Events

mRNA-1083 is a drug developed by Moderna for the following indication: Combination vaccine against influenza and COVID-19. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1283 - FDA Regulatory Timeline and Events

mRNA-1283 is a drug developed by Moderna for the following indication: Next Generation COVID-19. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1287 - FDA Regulatory Timeline and Events

mRNA-1287 is a drug developed by Moderna for the following indication: Endemic HCoV. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1345 - FDA Regulatory Timeline and Events

mRNA-1345 is a drug developed by Moderna for the following indication: Respiratory Syncytial Virus (RSV). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-1769 - FDA Regulatory Timeline and Events

mRNA-1769 is a drug developed by Moderna for the following indication: Mpox Vaccine. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

mRNA-4157/V940 (KEYTRUDA) - FDA Regulatory Timeline and Events

mRNA-4157/V940 (KEYTRUDA) is a drug developed by Moderna for the following indication: Provide an additive benefit and enhance T cell-mediated destruction of tumor cells. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Nova 301 - FDA Regulatory Timeline and Events

Nova 301 is a drug developed by Moderna for the following indication: for multiple norovirus genotypes. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SPIKEVAX (COVID-19 Vaccine, mRNA) - FDA Regulatory Timeline and Events

SPIKEVAX (COVID-19 Vaccine, mRNA) is a drug developed by Moderna for the following indication: COVID-19 in individuals 18 years of age and older. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

V940-001 - FDA Regulatory Timeline and Events

V940-001 is a drug developed by Moderna for the following indication: for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Moderna FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Moderna (MRNA) has reported FDA regulatory activity for the following drugs: mRNA-1345, COVID-19 vaccine, mRNA-4157/V940 (KEYTRUDA), SPIKEVAX (COVID-19 Vaccine, mRNA), mRNA-1010, mRNA-1283, mRNA-1018, mRNA-1083, Nova 301, mRNA-1287, mRNA-1769 and V940-001.

The most recent FDA-related event for Moderna occurred on June 30, 2025, involving mRNA-1010. The update was categorized as "Positive Results," with the company reporting: "Moderna, Inc. announced positive results from a Phase 3 efficacy study (P304) evaluating the relative vaccine efficacy (rVE) against influenza illness of mRNA-1010, the Company's seasonal influenza (flu) vaccine candidate, compared to a licensed standard-dose seasonal influenza vaccine in adults aged 50 years and older. mRNA-1010 achieved the most stringent superiority criterion prespecified in the protocol, with an rVE of 26.6% (95% CI; 16.7%, 35.4%) in the overall study population."

Current therapies from Moderna in review with the FDA target conditions such as:

  • Respiratory Syncytial Virus (RSV) - mRNA-1345
  • Covid-19 - COVID-19 vaccine
  • Provide an additive benefit and enhance T cell-mediated destruction of tumor cells. - mRNA-4157/V940 (KEYTRUDA)
  • COVID-19 in individuals 18 years of age and older - SPIKEVAX (COVID-19 Vaccine, mRNA)
  • Quadrivalent Seasonal Flu - mRNA-1010
  • Next Generation COVID-19 - mRNA-1283
  • pandemic influenza vaccine - mRNA-1018
  • Combination vaccine against influenza and COVID-19. - mRNA-1083
  • for multiple norovirus genotypes. - Nova 301
  • Endemic HCoV - mRNA-1287
  • Mpox Vaccine - mRNA-1769
  • for Adjuvant Treatment of Patients with Resected High-Risk (Stage IIB-IV) Melanoma - V940-001

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:MRNA) was last updated on 7/10/2025 by MarketBeat.com Staff
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