Latest changes
FDA Variance Approval Letter to Dapper Rave, LLC
The Food and Drug Administration (FDA) has issued a variance approval letter to Dapper Rave, LLC, through its Center for Devices and Radiological Health (CDRH). This document signifies an approval for a specific variance requested by the company.
FDA Decision on Tradipitant New Drug Application Refusal
The Food and Drug Administration (FDA) has issued a final decision regarding the new drug application for Tradipitant. The agency has decided to refuse to approve the application, based on a proposal to do so. The specific details of the decision are confidential business information, but a redacted version is available.
FDA Acknowledgment Letter to Axion Laser
The Food and Drug Administration (FDA) has issued an acknowledgment letter from its Division of Management and Budget (DMB) to Axion Laser. This notice confirms receipt of a submission, though no specific details about the submission's content or purpose are provided in the available information.
FDA Variance Application from Ingram Planetarium
The Food and Drug Administration (FDA) has posted a variance application from Ingram Planetarium. The application is available for review on Regulations.gov, with the author listed as CDRH.
Citizen Petition Filed by Premier Research International LLC
Premier Research International LLC has filed a citizen petition with the Food and Drug Administration (FDA) regarding regulatory matters. The petition is available for public review and comment.
FDA Acknowledgment Letter to Laina Callow
The Food and Drug Administration (FDA) has issued an acknowledgment letter to Laina Callow regarding a submission. The document is a redacted version of an acknowledgment letter from the FDA's Division of Management and Budget (DMB) to Laina Callow, authored by CDRH.
FDA CDER Final Response Letter to Age Reversal Unity
The FDA's Center for Drug Evaluation and Research (CDER) has issued a final response letter to Age Reversal Unity regarding their submissions. The document is available through the Regs.gov portal.
FDA Acknowledgement Letter to Premier Research International, LLC
The Food and Drug Administration (FDA) has issued an acknowledgement letter to Premier Research International, LLC. This notice confirms receipt of a submission, though no specific details about the submission's content or regulatory implications are provided.
FDA Acknowledges Letter to DePaul University
The Food and Drug Administration (FDA) has acknowledged receipt of a letter from DePaul University's Idea Realization Laboratory. This notice serves as an acknowledgment of the correspondence, with no further regulatory action or guidance provided at this time.
FDA Variance Request from Laina Callow - Comment Period Closed
The Food and Drug Administration (FDA) has closed the comment period for a variance request submitted by Laina Callow. The application, authored by CDRH, was available for public comment on regulations.gov.
FDA Final Response Letter to Athyna Pharma LLC
The Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) has issued a final response letter to Athyna Pharma LLC. This document provides specific feedback and guidance related to the company's pharmaceutical development or regulatory submissions.
FDA CDRH Variance Approval Letter to Axion Laser
The FDA's Center for Devices and Radiological Health (CDRH) has issued a variance approval letter to Axion Laser. This document grants a specific variance, indicating an approved deviation from standard regulatory requirements for a particular product or process.
DePaul University Variance Application
The FDA has posted a variance application submitted by DePaul University's Idea Realization Laboratory. The document is available for review on the Regs.gov platform. No specific compliance actions or deadlines are indicated for other entities.
Cancer Treatment Using TTFields and Interferon Gamma Compositions
The USPTO has published a new patent application detailing compositions, systems, and methods for treating cancer using Tumor Treating Fields (TTFields) in combination with interferon gamma. The application, filed on September 18, 2025, outlines a method for reducing cancer cell viability and tumor volume.
Patent Application: Autism Symptom Treatment via Neurotensin Receptor Activation
The USPTO has published a new patent application (US20260083820A1) from the New York Institute of Technology for methods and formulations to treat autism symptoms by activating neurotensin receptor 1 (NTSR1) without causing significant lethargy. The application was filed on October 3, 2025.
Ocular Insulin Delivery Enhanced by Prostaglandin Analogues Patent Application
The USPTO has published a patent application (US20260083822A1) for a novel ocular insulin delivery system. The invention utilizes prostaglandin analogues to enhance insulin permeability across ocular tissues, offering a non-invasive alternative to injections for therapeutic effects.
Wound healing composition with amino acids and fish collagen
The USPTO has published a new patent application detailing a composition for promoting wound healing. The composition includes an amino acid mixture and fish collagen, with a method for its administration also described. This application was filed on September 20, 2024.
Patent Application for DNase Enzyme Therapy for Tumor Microenvironment Immunomodulation
The USPTO has published a patent application (US20260083827A1) filed by CLS THERAPEUTICS LIMITED for methods of immunomodulating the tumor microenvironment using DNase enzyme therapy. The application details methods involving the administration of DNase enzyme, alone or with other agents, to combat immunosuppressive tumor cell microenvironments.
Patent Application for Biodegradable Particles Delivering Therapeutic Agents
The USPTO has published a new patent application (US20260083830A1) for biodegradable polymeric particles designed for the extended, controlled release of positively charged therapeutic agents at neutral pH. The application details microparticles and nanoparticles comprising an uncapped polymer matrix and a net positively charged therapeutic agent.
USPTO Patent Application for WNT-Related Cancer Vaccines
The USPTO has published a patent application (US20260083831A1) filed by Geneos Therapeutics, Inc. The application details compositions and methods for treating WNT-related cancers using nucleic acid sequences encoding tumor-specific antigens, potentially in combination with checkpoint inhibitors.
Novel agent for Alzheimer's treatment using dynamin 1 peptide
The USPTO has published a new patent application (US20260083826A1) from the Okinawa Institute of Science and Technology School Corporation for a novel agent to treat Alzheimer's disease. The application describes a peptide corresponding to dynamin 1, potentially encapsulated in nanoparticles for improved brain delivery.
Patent Application: Vaccine for Bordetella pertussis using antigen peptides
The USPTO has published a patent application (US20260083833A1) for a vaccine against Bordetella pertussis using antigen peptides. The application details a method for preventing infection by targeting specific peptides processed and presented by CD4+ T cells. This relates to ongoing research and development in vaccine technology.
Immune Cells Target EpCAM for Tumor Treatment
The USPTO has published a patent application (US20260083843A1) from SUZHOU IMMUNOHEAD BIOTECHNOLOGY CO., LTD. The application details the use of immune cells that target EpCAM for the prevention or treatment of metastatic tumors expressing EpCAM.
Cellicure, Inc. Patent Application for Engineered Immune Cells
The USPTO has published a patent application (US20260083845A1) filed by Cellicure, Inc. on September 22, 2023. The application details engineered immune cells, specifically chimeric antigen receptors (CARs) for enhanced killing activities, primarily targeting cancer treatment.
USPTO Patent Application: Polynucleotides Targeting NR4A3
The USPTO has published a patent application (US20260083846A1) filed by Lyell Immunopharma, Inc. The application describes polynucleotides designed to target the NR4A3 gene and their potential use in treating diseases, including cancer. The patent is scheduled to be published on March 26, 2026.
Patent for Radiation Dose Enhancement and Tumor Delineation
The USPTO has published a new patent application (US20260083850A1) for compounds, compositions, and methods related to radiation dose enhancement and tumor delineation. The application, assigned to the University of Connecticut, focuses on using barium nanoparticles for improved radiation therapy and tumor identification.
Proteoglycan Mimetics for Wound Healing and Angiogenesis
The USPTO has published a new patent application, US20260083852A1, detailing proteoglycan mimetics for enhanced wound healing and angiogenesis. The application describes compounds designed to support tissue regeneration and promote vascular repair, potentially limiting systemic exposure to VEGF activity.
USPTO Patent for Therapeutic Compounds Treating Cancer
The USPTO has published patent application US20260085059A1 for therapeutic compounds and methods of use in treating cancer. The patent was assigned to Servier Pharmaceuticals LLC and lists Samuel V. Agresta et al. as inventors. The application was filed on May 7, 2025.
Chemical Compound with Triazine Group and Production Method
The USPTO has published a patent application (US20260085087A1) for a chemical compound comprising a triazine group and its production method. The application relates to novel nucleotides and oligonucleotides with modified phosphate groups, potentially useful in diagnostics, gene therapy, and treating bacterial and viral diseases, including COVID-19.
CAR T-cell therapy combined with BTK inhibitors for cancer
The USPTO has published a new patent application (US20260083848A1) detailing a combination therapy for cancer treatment. The application describes the use of CAR T-cell therapy with BTK inhibitors for treating hematological malignancies. This represents a new disclosure in the field of cancer therapeutics.
Modified T-Cells for Bladder Cancer Treatment Application
The USPTO has published a patent application (US20260083849A1) detailing a method for treating bladder cancer using modified immunoresponsive cells. The application was filed on September 7, 2023, and is related to therapeutic applications in oncology.
Antimicrobial Compositions Patent Application
The USPTO has published a patent application (US20260083126A1) for antimicrobial compositions containing organosulfur compounds. The application, filed on September 8, 2023, describes compounds useful for treating microbial infections and for cleaning, disinfecting, or agricultural use.
Patent Application: T-cell receptors target mutant RAS for cancer treatment
The USPTO has published patent application US20260083847A1 concerning T-cell receptors and compositions for treating cancer associated with mutant RAS. The application details methods and compositions involving T-cell receptors that bind to specific mutant RAS peptide fragments in the context of specific HLA types.
Meloxicam Pharmaceutical Composition and Application
The USPTO has published a patent application (US20260083748A1) for a pharmaceutical composition containing meloxicam, a composite solvent, and an acidic pH regulator. The assignee is Beijing Tide Pharmaceutical Co., Ltd. This application details a preparation method and its application, focusing on a formulation that avoids organic solvents for increased safety and reduced environmental impact.
Adjuvant Composition with STING Agonist and Aluminium Hydroxide
The USPTO has published a patent application by GlaxoSmithKline Biologicals SA for an adjuvant composition comprising a STING agonist and an aluminum-based adjuvant. The application details immunogenic compositions and their use in immunizing subjects.
GalNAc Monomer for Liver-Targeted Nucleic Acid Drug Delivery
The USPTO has published a patent application detailing a GalNAc monomer for liver-targeted delivery of small nucleic acid drugs. The application, filed by inventors Zeao Huang et al., describes a compound that enhances drug efficacy through efficient liver targeting.
Patent Application: Iron Metabolism Targets for Obesity Treatment
The USPTO has published a new patent application (US20260085321A1) detailing methods for treating obesity by inhibiting specific iron metabolism genes. The application, filed on September 24, 2025, by inventor Richard Possemato, proposes inducing weight loss through increased lipid catabolism.
Engineered Ketoreductases for Chiral Alcohol Preparation
The USPTO has published a patent application (US20260085334A1) for engineered ketoreductase polypeptides developed by Enzymaster (Ningbo) Bio-Engineering Co., Ltd. The patent describes enzymes capable of preparing chiral alcohols with high catalytic activity, stereoselectivity, thermal stability, and solvent tolerance.
Method for Producing Oil Composition via Biomass Fermentation
The USPTO has published a patent application detailing a method for producing an oil composition through the fermentation of biomass using specific yeast strains. The application outlines a preparation stage, a fermentation stage with controlled temperature and pH, and an oil procurement stage involving mechanical cell lysis.
Patent Application for Metabolism Disease Therapeutic Agents
The USPTO has published a new patent application (US20260085322A1) for therapeutic agents targeting metabolism-associated diseases, such as MAFLD. The application was filed on September 6, 2023, by inventors from the USPTO.
Patent Application for Plant Regulatory Elements and Uses
The USPTO has published a patent application (US20260085324A1) detailing novel synthetic small nuclear RNA (snRNA) promoters for CRISPR-mediated gene modifications in plants. The application, filed on October 3, 2025, includes methods and compositions for developing plants with modified genomes using these promoters.
Patent Application for Pseudomonas Recombinant Protein Expression
The USPTO has published a new patent application, US20260085338A1, detailing a Pseudomonas sp. strain for recombinant protein expression. The application was filed on September 6, 2023, and relates to novel expression systems for biotechnological applications.
Method for Detecting Polynucleotide Analyte Using CRISPR/Cas Effector
The USPTO has published a new patent application detailing a method for detecting polynucleotide analytes using CRISPR/Cas effector technology. The application, filed by inventors from USPTO, describes a method involving a cleaving agent with flap endonuclease activity and a type V CRISPR/Cas effector protein, specifically a Cast2 protein.
Patent Application: Disruption of GROOT Gene Function Increases Plant Biomass
The USPTO has published a patent application (US20260085325A1) from the Salk Institute for Biological Studies detailing methods to enhance plant biomass and seed size by reducing the expression of GROOT1, GROOT2, and GROOT3 genes. The application describes compositions and transformed plants generated using these methods.
Viral Protein Expression Patent Application
The USPTO has published a new patent application, US20260085328A1, filed on September 8, 2023. The application describes methods and systems for producing adeno-associated virus (AAV) particles using insect cells.
Methods for rapid multiplex HLA genotyping and transcript quantitation
The USPTO has published a new patent application detailing methods for rapid multiplex HLA genotyping and transcript quantitation using nanopore technology. The application, assigned to The University of North Carolina at Chapel Hill, outlines techniques for determining HLA status and genotyping donor cells for transplantation.
Breast Cancer Detection Kit, Device, and Method Patent Application
The USPTO has published a patent application (US20260085359A1) from TORAY INDUSTRIES, INC. for a breast cancer detection kit, device, and method. The application describes a kit or device comprising nucleic acids that specifically bind to a miRNA in a subject's sample, and a method for detecting breast cancer by measuring the miRNA in vitro.
US Patent Application for PDCD1 Knockout RNA Molecule
The USPTO has published a new patent application (US20260085331A1) for an RNA molecule designed for biallelic knockout of PDCD1. The application, filed on September 18, 2023, details compositions comprising RNA molecules with specific guide sequences and their methods of use.
Alpha-amylase variants and polynucleotides patent application
The USPTO has published a new patent application, US20260085261A1, from Novozymes A/S concerning alpha-amylase variants and related polynucleotides. The application details specific molecular constructs and their potential uses.
Chimeric Transposases and Fusion Proteins Patent Application
The USPTO has published a new patent application (US20260085332A1) detailing chimeric transposases and fusion proteins. The application, filed on October 3, 2025, by inventors Joseph S. Lucas, Blair B. Madison, and Olga Batalov, covers polynucleotides, vectors, and methods for modifying cells using these proteins.
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