The U.S. FDA sent out a friendly reminder to more than 2,200 sponsors and researchers, associated with more than 3,000 clinical trials, who may be delinquent in disclosing the results of those studies on clinicaltrials.gov.

Tr1x Inc. was founded with a simple but ambitious goal: to change how autoimmune and inflammatory diseases are treated, moving away from chronic treatment and toward durable cures. “We are trying to flip the script on regulatory T cells (Tregs),” Tr1x CEO David de Vries told BioWorld. “The goal is to reset the immune system rather than continuously suppress it, and we believe we have a unique technology to do that.”

Becoming the first and only fully FDA-approved treatment for focal segmental glomerulosclerosis (FSGS), Travere Therapeutics Inc.’s Filspari (sparsentan) has gained access to a second lucrative market with a regulatory package that validates proteinuria as a surrogate endpoint.

Replimune Group Inc. received another complete response letter (CRL) from the U.S. FDA for immunotherapy vusolimogene oderparepvec to treat advanced melanoma, sending shares plunging by more than 19% on the April 10 PDUFA date.

The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.

The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date.

Endospan Ltd. Secured U.S. premarket approval for its Nexus aortic arch stent graft, bringing the company closer to being acquired by Artivion Inc. Under the terms of an existing agreement, Artivion has an option to acquire Endospan at any time within 90 days of the FDA approval.

The U.S. FDA issued a warning letter to Medline Inc. having identified several issues with its Namic brand angiographic control syringes and manifolds used for the intra-arterial or intravenous administration of radiographic contrast media. The agency warned the company that failure to promptly address the violations identified in the letter may result in regulatory action being initiated, including seizure, injunction and civil money penalties.

With three rare pediatric disease priority review vouchers (RPD PRVs) awarded just since the end of March, the nearly year-and-a-half lapse in the program’s reauthorization seems to have had little short-term impact. The three new vouchers bring the total RPD PRVs granted so far this year to seven – one more than the agency issued all last year and down two from the nine given in 2024.