January 2023 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in January 2023 for investigational products in development.
Diagnosis & Disease Information
Belimumab Granted Orphan Drug Status for Systemic Sclerosis
Belimumab is a B-lymphocyte stimulator-specific inhibitor.
Avapritinib Gets Priority Review for Indolent Systemic Mastocytosis
The sNDA is supported by data from the phase 2 PIONEER trial that evaluated the efficacy and safety of avapritinib in patients with indolent systemic mastocytosis.
FDA Approves Room Temp Storage Conditions for Asceniv and Bivigam
The new room temperature storage condition for Asceniv and Bivigam is immediately effective.
September 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in September 2022 for investigational products in development.
Firdapse Approval Expanded to Children With Lambert-Eaton Myasthenic Syndrome
The approval was based on data from an expanded access program which evaluated the safety of amifampridine in 21 pediatric patients for at least 1 year.
Leniolisib Gets Priority Review for Activated Phosphoinositide 3-Kinase Delta Syndrome
Leniolisib is a small molecule inhibitor of the delta isoform of the 110 kDa catalytic subunit of class IA PI3K with immunomodulating and potentially antineoplastic activities.
Continuation of Anti-TNF for IBD After 24 Weeks of Pregnancy Beneficial
Risk for maternal IBD relapse and prematurity reduced with continuation of anti-TNF after 24 weeks of pregnancy
Reduction in Swollen, Tender Joints Greater With Litifilimab in Lupus
Most secondary end points did not support the results of the analysis for the primary end point
August 2022 Recap: Drug Pipeline Update
Stay up-to-date on the latest drugs in development.
