Recent changes
FormPour Warning Letter - Unapproved New Drug Sales via eBay
FDA issued a warning letter to FormPour (Shuja Arshad) for selling an unapproved new drug product, the 'SMGT-GLT-1 Nano Microneedle Patch,' on eBay. The product makes unapproved claims for treating Type 2 diabetes, weight loss, and cardiovascular protection, violating sections 301(d) and 505(a) of the FD&C Act. The recipient has 15 working days to respond with corrective actions or face seizure and injunction.
Pure Indulgence Aesthetics - DSCSA Trading Partner and Product Tracing Violations
FDA issued a Warning Letter to Pure Indulgence Aesthetics, a medical spa in Southlake, TX, identifying DSCSA violations under Section 582(d) of the FD&C Act. Investigators found the firm dispensed significantly more Botox units than documented in purchase records from AbbVie, indicating potential sourcing from unauthorized trading partners. The firm must respond with corrective actions within the specified timeframe.
DNV Healthcare Hospital Accreditation Comment
DNV Healthcare submitted a public comment to CMS on proposed hospital accreditation standards (CMS-2026-1288). The comment was filed through Regulations.gov as part of the federal rulemaking consultation process. The specific content of the comment is not visible in this form submission record.
DNV Healthcare Seeks Continued CMS Hospital Accreditation Recognition
CMS published a notice acknowledging receipt of DNV Healthcare USA Inc.'s application for continued recognition as a national accrediting organization for hospital accreditation. The application would allow DNV to continue certifying hospitals for participation in Medicare and Medicaid programs under Section 1865(a)(1)(A) of the Social Security Act. Public comments are being accepted until May 11, 2026.
DEA Baltimore Seizes Over 10,000 Fentanyl-Laced Gel Capsules
DEA Baltimore division and law enforcement partners seized over 10,000 gel capsules containing fentanyl in Baltimore. The counterfeit capsules were packaged to resemble candy or vitamins and were prepared for immediate street distribution. DEA issued a public safety alert warning the public not to be deceived by the deceptive packaging.
Washington University Patents UTI Treatment Using Hemolysin Inhibitor
The USPTO published Washington University's patent application (US20260098073A1) for compositions and methods treating urinary tract infection and sepsis using alpha-hemolysin (HlyA) inhibiting agents. The technology includes soluble LDLR-Fc fusion proteins, clathrin-mediated endocytosis inhibitors, and anti-LDLR antibodies targeting E. coli hemolysin. This grants Washington University exclusive IP rights over these therapeutic compositions.
CAR TCR Cell Therapy Patent Improves Cytokine Signaling
USPTO published patent application US20260098074A1 by inventors Ruth E. Winter and Saikat Banerjee for CAR and/or TCR cell therapy improving cytokine signaling. The patent covers methods for enhancing immune cell function through improved cytokine signaling pathways in cell therapy applications. The application was filed on 2025-07-15.
Modified LGICs with Altered Ligand Binding, Ion Pore Domains
USPTO published patent application US20260098076A1 for modified ligand-gated ion channels (LGICs) with altered ligand binding domains and ion pore domains. The invention covers exogenous LGIC ligands, methods for modulating ion transport and cell excitability in mammals, and methods for treating channelopathies. The application was filed on February 24, 2025.
METHOD FOR TREATING MEMBRANOUS NEPHROPATHY WITH TACI-FC FUSION PROTEIN
USPTO published patent application US20260098077A1 for a method of treating membranous nephropathy using TACI-Fc fusion protein. The application, filed September 28, 2023, discloses dosage schemes, administration intervals, and clinical efficacy data showing good safety profiles in patients.
Methods for Constructing Conjugates Using Ortho-Phthalaldehyde
USPTO published Patent Application US20260098054A1 disclosing methods for constructing conjugates using ortho-phthalaldehyde. The method involves reacting an amine-containing component with a thiol-containing component in comparable mole ratios to generate a conjugate bearing a substituted or unsubstituted 1-thio-isoindole structure. Inventors are Xuechen LI and Hey Pui CHEUNG. The application was filed on August 22, 2023.
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