If a recent warning letter is anything to go by, the U.S. FDA could be using the 2013 Drug Supply Chain Security Act as another enforcement tool to shut down unauthorized suppliers by clamping down on the dispensers that purchase their unapproved drug products.

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.

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.

In a move that could give patients quick access to drugs their doctors prescribe, the U.S. CMS is proposing a rule giving insurers no more than 24 hours to respond to urgent prior authorization requests and 72 hours for standard requests. The rule also would require full disclosure of claims denials and appeals outcomes.

Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>

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.

Everest Medicines Ltd. has agreed to acquire a Singapore-based commercial unit of Hasten Biopharmaceuticals (Asia) Ltd. for $150 million up front, gaining market authorization holder rights to 14 marketed products originally developed by Takeda Pharmaceutical Co. Ltd.

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.