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

246
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,...
246
Obedience01:08

Obedience

35.2K
According to obedience research, we may harm others under the forceful pressures of an authority figure (Milgram, 1974). How about if the inappropriate orders were delivered with less force? The increasing interdependence between nurses and physicians compelled Hofling and his colleagues to explore nurses’ reactions to a potentially harmful medical request made by the perceived authority figure, the doctor (Hofling, Brotzman, Dalrymple, Graves, & Pierce, 1966). In this situation,...
35.2K
Ethics in Research01:56

Ethics in Research

25.4K
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
25.4K

You might also read

Related Articles

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

Sort by
Same author

Deuruxolitinib: New Approval.

Clinical drug investigation·2026
Same author

Bevifibatide: First Approval.

Drugs·2026
Same author

Correction: Ifupinostat: First Approval.

Drugs·2026
Same author

Ifupinostat: First Approval.

Drugs·2025
Same author

Fosrolapitant/Palonosetron: First Approval.

Drugs·2025
Same author

Nipocalimab: First Approval.

Drugs·2025
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: Jan 22, 2026

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells
10:03

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells

Published on: August 1, 2013

17.5K

Remibrutinib: First Approval.

Simon Fung1

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

Drugs
|January 20, 2026
PubMed
Summary
This summary is machine-generated.

Remibrutinib is a new oral Bruton's tyrosine kinase (BTK) inhibitor approved for chronic spontaneous urticaria (CSU) in adults. This marks a significant advancement for patients with symptomatic CSU unresponsive to antihistamines.

More Related Videos

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression
10:29

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression

Published on: November 12, 2010

40.5K
Isolation and Derivation of Mouse Embryonic Germinal Cells
14:01

Isolation and Derivation of Mouse Embryonic Germinal Cells

Published on: October 22, 2009

16.6K

Related Experiment Videos

Last Updated: Jan 22, 2026

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells
10:03

Generation of Recombinant Arenavirus for Vaccine Development in FDA-Approved Vero Cells

Published on: August 1, 2013

17.5K
The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression
10:29

The NeuroStar TMS Device: Conducting the FDA Approved Protocol for Treatment of Depression

Published on: November 12, 2010

40.5K
Isolation and Derivation of Mouse Embryonic Germinal Cells
14:01

Isolation and Derivation of Mouse Embryonic Germinal Cells

Published on: October 22, 2009

16.6K

Area of Science:

  • Pharmacology
  • Immunology
  • Dermatology

Background:

  • Chronic spontaneous urticaria (CSU) is a debilitating condition often refractory to standard treatments.
  • Bruton's tyrosine kinase (BTK) plays a key role in immune cell activation relevant to CSU pathogenesis.

Purpose of the Study:

  • To summarize the development milestones of remibrutinib for CSU.
  • To highlight the first regulatory approval of remibrutinib for symptomatic CSU.

Main Methods:

  • Review of preclinical and clinical development data for remibrutinib.
  • Analysis of regulatory submission and approval timelines.

Main Results:

  • Remibrutinib, a selective BTK inhibitor, has undergone extensive development.
  • First approval granted in the USA on September 30, 2025, for adult patients with symptomatic CSU despite H1-antihistamine treatment.
  • Subsequent approvals in China and ongoing reviews in the EU and Japan.

Conclusions:

  • Remibrutinib represents a novel therapeutic option for CSU.
  • The approval signifies a major step forward in managing CSU, offering hope to patients with unmet needs.