IMAAVY demonstrated a swift and significant decrease in IgG levels, a primary driver of gMG, in key adult and pediatric trials.
Regulatory
Adult GCA can now be treated with RINVOQ (upadacitinib), the first and only oral Janus Kinase (JAK) inhibitor authorized for this purpose.
The gadget analyzes images using artificial intelligence to achieve a degree of diagnosis accuracy that is not achievable with conventional manual grading techniques.
AbbVie declared that they had submitted the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE) to the United States FDA for the treatment of moderate to severe glabellar lines. The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an […]
Columvi therapy provides a much-needed, off-the-shelf, fixed-duration alternative for transplant ineligible individuals.
Phase 3 tests showing Dupixent dramatically decreased itching and hives when compared to a placebo led to approval.
Lecanemab is the only approved Aβ monoclonal antibody that binds and clears hazardous protofibrils.
The FDA’s animal testing requirement will be decreased, modified, or potentially replaced utilizing a variety of methodologies.
IgG4-RD can arise in various organs, causing fibrosis and irreversible organ damage. Understanding how organ damage occurs is key to making an accurate diagnosis of IgG4-RD.
FDA stated in the letter that the NDA “failed to demonstrate efficacy in adequate and well controlled studies in treating ocular symptoms associated with dry eyes”.
