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Emergent Biosolutions (EBS) FDA Events

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FDA Events for Emergent Biosolutions (EBS)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Emergent Biosolutions (EBS). Over the past two years, Emergent Biosolutions has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ACAM2000®, Ebanga, and NARCAN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Emergent Biosolutions' Drugs in FDA Review

ACAM2000® - FDA Regulatory Timeline and Events

ACAM2000® is a drug developed by Emergent Biosolutions for the following indication: For Mpox Indication. 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.

Ebanga - FDA Regulatory Timeline and Events

Ebanga is a drug developed by Emergent Biosolutions for the following indication: Treatment for Ebola. 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.

NARCAN - FDA Regulatory Timeline and Events

NARCAN is a drug developed by Emergent Biosolutions for the following indication: Nasal Spray as manifested by respiratory and/or severe central nervous system depression. 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.

Emergent Biosolutions FDA Events - Frequently Asked Questions

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

In the past two years, Emergent Biosolutions (EBS) has reported FDA regulatory activity for the following drugs: NARCAN, Ebanga and ACAM2000®.

The most recent FDA-related event for Emergent Biosolutions occurred on March 13, 2025, involving NARCAN. The update was categorized as "Provided Update," with the company reporting: "Emergent BioSolutions Inc. is strengthening relationships with partners across sectors and continuing its commitment to ensuring widespread opioid emergency preparedness as opioid overdose death rates continue to decline nationwide for the first time in five years.1 These efforts include working with organizations to expand access to NARCAN® Nasal Spray and educate the public on how to respond to an opioid overdose emergency."

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

  • Nasal Spray as manifested by respiratory and/or severe central nervous system depression. - NARCAN
  • Treatment for Ebola - Ebanga
  • For Mpox Indication - ACAM2000®

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 (NYSE:EBS) was last updated on 7/9/2025 by MarketBeat.com Staff
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