Phase III
The FDA approved the latest indication for Rinvoq (upadacitinib) based on data from two Phase III studies, SELECT-PsA 1 and SELECT-PsA 2.
These results set Lilly up well to submit a Biologics License Application (BLA) in the first half of 2022.
The FDA’s approval of Xeljanz is based on Pfizer’s Phase III multicenter, double-blind, placebo-controlled study. Here are more details about the study.
The 63rd ASH Annual Meeting and Exposition is wrapping up today, with dozens providing updates on clinical trials and preclinical research. Here’s a highlight of just a few of those stories.
Cidara Therapeutics and Mundipharma today shared positive topline results from their Phase III trial on the use of rezafungin for candidemia and invasive candidiasis.
As of now, six studies related to islatravir are on full clinical hold, while seven are on partial clinical hold. Here are more updates on the development of this drug.
Making its ASH debut this year was Novartis’ T-Charge CAR-T platform. Novartis presented early data from two first-in-human dose-escalation trials: YTB323 and PHE885.
Takeda will present nine abstracts at the annual ASH meeting, including data for its hemophilia program, as well as announcing a new sickle cell disease program.
BrainStorm Cell Therapeutics is making a strong comeback after the FDA was a little impressed with Phase III results of amyotrophic lateral sclerosis treatment.
At the ASH meeting, Bristol Myers Squibb and Kite Pharma presented promising data from CAR-T programs aimed at relapsed or refractory large B-cell lymphoma.
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