Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

FDA Approved Drugs: Changes to Approved Drugs

84
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
84
Drug Regulation01:25

Drug Regulation

2.5K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.5K
Bioequivalence studies: Biowaivers01:13

Bioequivalence studies: Biowaivers

81
Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
81
Mitral Regurgitation III: Medical Management01:25

Mitral Regurgitation III: Medical Management

125
Mitral regurgitation (MR) is characterized by retrograde blood circulation from the left ventricle into the left atrium due to inadequate mitral valve closure. The severity of the condition, symptoms, and underlying cause determine treatment strategies.Monitoring and Pharmacological TreatmentPatients with mild to moderate MR typically do not need immediate intervention but regular monitoring to assess progression and guide treatment. Patients with mild MR should have an echocardiogram every 3-5...
125

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Correction to: Daridorexant: First Approval.

Drugs·2022
Same author

Gefapixant: First Approval.

Drugs·2022
Same author

Daridorexant: First Approval.

Drugs·2022
Same author

Cabozantinib plus Nivolumab: A Review in Advanced Renal Cell Carcinoma.

Targeted oncology·2022
Same author

Envafolimab: First Approval.

Drugs·2022
Same author

Correction to: Avatrombopag: A Review in Thrombocytopenia.

Drugs·2021
Same journal

Botulinum Toxin Type A for Trigeminal and Postherpetic Neuralgia: An Umbrella Review of Systematic Reviews.

Drugs·2026
Same journal

Biologics and Small Molecule Inhibitors: Novel Therapeutic Strategies for Cutaneous Adverse Drug Reactions.

Drugs·2026
Same journal

Use of Sedative-Hypnotic Drugs and the Risk of Developing Alzheimer's Disease: A Systematic Review, Meta-Analysis and Meta-Regression.

Drugs·2026
Same journal

Relacorilant: First Approval.

Drugs·2026
Same journal

Developmental Progress and Future Potential for Inhaled Biologics in the Treatment of Respiratory Diseases.

Drugs·2026
Same journal

Linerixibat: First Approval.

Drugs·2026
See all related articles

Related Experiment Video

Updated: Nov 21, 2025

High-Throughput Cardiotoxicity Screening Using Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Monolayers
14:03

High-Throughput Cardiotoxicity Screening Using Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Monolayers

Published on: March 24, 2023

2.2K

REGN-EB3: First Approval.

Anthony Markham1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

Drugs
|January 12, 2021
PubMed
Summary
This summary is machine-generated.

REGN-EB3, a combination of three monoclonal antibodies, is now FDA-approved for treating Zaire ebolavirus infection. This groundbreaking treatment offers new hope for patients battling Ebola virus disease.

More Related Videos

In Vivo Functional Study of Disease-associated Rare Human Variants Using Drosophila
06:41

In Vivo Functional Study of Disease-associated Rare Human Variants Using Drosophila

Published on: August 20, 2019

14.0K
Production of Human Neurogenin 2-Inducible Neurons in a Three-Dimensional Suspension Bioreactor
07:21

Production of Human Neurogenin 2-Inducible Neurons in a Three-Dimensional Suspension Bioreactor

Published on: March 17, 2023

1.9K

Related Experiment Videos

Last Updated: Nov 21, 2025

High-Throughput Cardiotoxicity Screening Using Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Monolayers
14:03

High-Throughput Cardiotoxicity Screening Using Mature Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Monolayers

Published on: March 24, 2023

2.2K
In Vivo Functional Study of Disease-associated Rare Human Variants Using Drosophila
06:41

In Vivo Functional Study of Disease-associated Rare Human Variants Using Drosophila

Published on: August 20, 2019

14.0K
Production of Human Neurogenin 2-Inducible Neurons in a Three-Dimensional Suspension Bioreactor
07:21

Production of Human Neurogenin 2-Inducible Neurons in a Three-Dimensional Suspension Bioreactor

Published on: March 17, 2023

1.9K

Area of Science:

  • Virology
  • Immunology
  • Pharmacology

Background:

  • Ebola virus disease (EVD) poses a significant public health threat, particularly Zaire ebolavirus.
  • Limited effective treatments have been available for EVD, necessitating the development of novel therapeutic strategies.

Purpose of the Study:

  • To summarize the development milestones of REGN-EB3 (INMAZEB®), a monoclonal antibody combination therapy.
  • To highlight the regulatory approval of REGN-EB3 by the US FDA for treating Zaire ebolavirus infection.

Main Methods:

  • REGN-EB3 comprises three fully-human monoclonal antibodies: atoltivimab, maftivimab, and odesivimab.
  • The efficacy and safety of REGN-EB3 were evaluated in clinical studies, including the PALM trial during an Ebola outbreak.

Main Results:

  • REGN-EB3 demonstrated significant efficacy in treating Zaire ebolavirus infection.
  • The PALM study results formed the basis for the US FDA approval.

Conclusions:

  • REGN-EB3 represents a major advancement in EVD treatment.
  • The FDA approval marks the first-ever approval for an EVD therapy, offering a critical new option for adult and pediatric patients.