The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with large B-cell lymphoma and follicular lymphoma approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Axicabtagene ciloleucel is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

The LimFlow™ System, PMA P220025, received U.S. Food and Drug Administration (FDA) approval on September 11, 2023. The purpose of this post-approval study is to provide additional information on a device designed to create a connection between the artery and vein in the Below The Knee (BTK) vascular system, using a minimally invasive approach. This procedure is only indicated for patients with “chronic limb-threatening ischemia” who are not likely to be helped with standard operations or procedures and are at risk of major amputation.

This SafeHeal study is designed to assess the overall safety of the low anterior resection (LAR) standard of care cancer treatment by establishing a definition of major complications. The current literature on standard of care reports adverse events/complications but does not provide a single endpoint that can be used to compare the safety of LAR cancer treatment to alternative therapies or treatments. This study will allow for the establishment of a new single safety endpoint for LAR standard-of-care cancer treatment.
   

 This study is evaluating the initial safety and efficacy of local injections of E-CEL UVEC cells, which are genetically engineered (pro-survival gene, E4ORF1+), human umbilical vein endothelial cells, as an experimental treatment of patients with chronic anal fissure (CAF) who have failed medical therapy (i.e., topical vasodilators ± botulinum injection). 

Experimental means that E-CEL UVEC is not approved by the U.S Food and Drug Adminstration. 

Chronic fecal incontinence (FI) is the recurrent unintended passage of mucus and/or liquid or solid stool for at least 6 months. Iltamiocel is an investigational cell therapy product that involves a medical procedure in which a participant's own muscle cells are collected, processed, and then injected into the tissues of the external anal sphincter. Investigational means it is not approved by the U.S. Food and Drug Administration (FDA). 
   

This clinical trial is for men (18 years or older) with metastatic castration-resistant prostate cancer (mCRPC).
   
The purpose of this study is to identify a dose of JANX007 that is well tolerated. 
   
JANX007 is experimental, which means that they are being tested and are not yet approved by the United States Food and Drug Administration (FDA).
   

This expanded access study is for men and women whose immune cells (T cells) were genetically engineered to create a treatment called brexucabtagene autoleucel, but the genetically engineered cells did not meet the U.S. Food and Drug Administration’s (FDA) approved criteria for release back to the participant for treatment. If the participant’s doctor feels that treatment with the commercially out-of-specification brexucabtagene autoleucel is still the best option, the participant can receive the out-of-specification product through this program.
   

The purpose of this research study is to evaluate the effect of Efruxifermin compared to placebo on achieving nonalcoholic steatohepatitis (NASH) resolution and fibrosis regression in participants with fibrosis stage 2 or 3.

 The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or recommended dose (RD) of SGR-1505.

SGR-1505 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 
   
In this study, SGR-1505 will be taken orally either once daily or every 12 hours.