Retifanlimab Under Review for Anal Squamous Cell Carcinoma
The BLA is supported by data from the POD1UM-202 trial that evaluated retifanlimab in 94 adults with locally advanced or metastatic SCAC who progressed after platinum-based chemotherapy.
Gastroenterology
FDA to Review Additional GI Cancer Indications for Nivolumab
The sBLA submissions were based on data from the CheckMate -649 and CheckMate -577 trials.
De-Escalation and Discontinuation of Biologics in IBD: What to Consider
Although the definition of remission varies, the goal of IBD treatment is to achieve and sustain remission.
Enhertu Gains Gastric Cancer Indication
The approval was based on data from the phase 2 DESTINY-Gastric01 trial.
First Treatment for Newly Diagnosed Light Chain Amyloidosis Approved
The approval was based on data from the open-label, active-controlled phase 3 ANDROMEDA study.
Novel Therapy Fast Tracked for GI Dysfunction in Peds Undergoing Heart Surgery
The designation is based on positive topline data from a phase 2 study of 120 adults following open-heart surgery.
Use of Direct Acting Antivirals With Potent Inducers Examined in Case Series
While DAAs have improved the treatment of chronic HCV infection by eliciting higher rates of sustained virologic response, they also interact with a number of agents that could potentially limit their effectiveness.
Clinical Remission Observed With Risankizumab in Crohn Disease Trials
Risankizumab is currently FDA-approved under the brand name Skyrizi for the treatment of moderate to severe plaque psoriasis.
New Drugs Approved in 2020
Visit our New Drug Products page to stay up-to-date on the latest drug approvals.
Generic Version of Amitiza Now Available
The Company has begun shipping both the 8mcg and 24mcg capsules; the capsules are supplied in 60-count bottles.
