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.
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.
- Drug:
- ACAM2000®
- Announced Date:
- August 29, 2024
- Indication:
- For Mpox Indication
Announcement
Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection.
AI Summary
Emergent BioSolutions announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) to expand the use of its ACAM2000® vaccine. Originally approved for preventing smallpox, ACAM2000® can now also be used to prevent mpox disease in individuals at high risk of infection. This updated indication is supported by previous human safety data and results from a well-controlled animal study showing the vaccine’s effectiveness against the mpox virus. Administered as a single dose using a bifurcated needle, the vaccine’s expansion comes at a time when robust prevention measures are crucial for public health. This FDA decision enhances the vaccine’s role in combating mpox and further strengthens Emergent BioSolutions’ portfolio in addressing critical infectious diseases.
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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.
- Drug:
- Ebanga
- Announced Date:
- September 12, 2024
- Indication:
- Treatment for Ebola
Announcement
Emergent BioSolutions announced that that it was awarded a contract modification executing an option period by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S.
AI Summary
Emergent BioSolutions has been awarded a $41.9 million contract modification by the Biomedical Advanced Research and Development Authority (BARDA), a part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services. The modification executes an option period that focuses on advancing drug substance engineering, scale-up process validation, long term stability, and commercial readiness for the production of Ebanga™, a treatment for Ebola virus disease.
This modification is a crucial step in Emergent’s ongoing scale-up program, which aims to enhance manufacturing capabilities and ensure preparedness against the Ebola virus. By progressing these activities, Emergent is positioning itself as a leader in developing critical medical countermeasures and meeting national health security needs.
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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.
- Drug:
- NARCAN
- Announced Date:
- March 13, 2025
- Indication:
- Nasal Spray as manifested by respiratory and/or severe central nervous system depression.
Announcement
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.
AI Summary
Emergent BioSolutions Inc. is strengthening relationships with partners across sectors to boost opioid emergency preparedness. The company is committed to ensuring wider access to NARCAN® Nasal Spray, the first FDA-approved over-the-counter naloxone product for treating opioid overdoses. Its efforts include a partnership with the NYC Building & Construction Industry Safety Fund, where training programs are being rolled out at job sites. These sessions educate construction workers on the signs of an opioid overdose and how to use NARCAN® Nasal Spray correctly, with each worker receiving an opioid emergency kit.
Additionally, Emergent is working with Pathway Healthcare to make NARCAN® available at multiple Mississippi locations. These joint measures come as opioid overdose death rates decline nationwide for the first time in five years, reinforcing the significant and lifesaving impact of public education and quick response strategies in opioid emergencies.
Read Announcement- Drug:
- NARCAN
- Announced Date:
- February 7, 2025
- Indication:
- Nasal Spray as manifested by respiratory and/or severe central nervous system depression.
Announcement
Emergent BioSolutions announced today that it is raising awareness of the Ready to Rescue initiative in New Orleans with pro football legend and NARCAN® Nasal Spray spokesperson, Emmitt Smith, as the city welcomes an anticipated 83,000 fans for the Big Game.
AI Summary
Emergent BioSolutions is raising awareness of its Ready to Rescue initiative in New Orleans ahead of the Big Game, where the city is expecting around 83,000 fans. The company is partnering with pro football legend Emmitt Smith, who is also a spokesperson for NARCAN® Nasal Spray. Smith, well-known for speaking about his personal connection to the opioid epidemic, will help educate the public on how to act in an opioid emergency. Through his “Lay, Spray, Stay” message, he explains the simple steps to use NARCAN® to reverse opioid overdoses.
The initiative includes an educational video that will be shown on local taxi television screens and a giveaway of hundreds of NARCAN® Nasal Spray cartons throughout the weekend. This public awareness campaign aims to empower New Orleans residents and visitors with the knowledge and tools to help save lives during opioid-related emergencies.
Read Announcement- Drug:
- NARCAN
- Announced Date:
- July 22, 2024
- Indication:
- Nasal Spray as manifested by respiratory and/or severe central nervous system depression.
Announcement
Emergent BioSolutions announced the shelf-life extension for NARCAN® Nasal Spray from three years (36 months) to four years (48 months) to all newly manufactured product.
AI Summary
Emergent BioSolutions has extended the shelf-life of its newly manufactured NARCAN® Nasal Spray from three years (36 months) to four years (48 months). This extension makes it the only 4 mg intranasal naloxone spray in Canada with a four-year expiration date. The change is aimed at improving access to naloxone, a life-saving medication used to reverse opioid overdoses from drugs such as heroin and fentanyl. The updated shelf-life means that community partners, caregivers, and patients now have an extended period to use this crucial product, ensuring readiness during opioid emergencies.
With the revised expiration date now in effect for all new product shipments, Emergent BioSolutions is helping to bolster responses to the opioid crisis. The longer shelf-life reinforces the commitment to provide a dependable, effective, and accessible solution to combat accidental opioid poisonings in communities across the country.
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