Rare disease news, mapped to the diseases behind the headlines. AI-classified across pipeline, policy, funding, science, and community.
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FDA has determined the regulatory review period for ADZYNMA, which is relevant for patent extension applications. This notice is part of the legal requirements for patent claims related to human biological products.
The FDA proposes to withdraw approval of three abbreviated new drug applications due to the ANDA holders' failure to submit required annual reports. This action opens a hearing opportunity for the affected companies to contest the proposal.
The Administration for Children and Families seeks a one-year extension and revisions to the ACF Uniform Project Description information collection, aiming to simplify the process with clearer language. This proposal is set to expire on March 31, 2026.
The Administration for Children and Families (ACF) proposes to extend data collection for its Generic Program-Specific Performance Progress Report. This initiative aims to enhance performance tracking for grant recipients, although it does not introduce significant changes.
The Administration for Children and Families seeks a 3-year extension for the LIHEAP Quarterly Reports, aiming to reduce redundancy and administrative burden. This proposal is set to expire on October 31, 2025.
The Administration for Children and Families seeks a 3-year extension for the Children's Justice Act Program Instruction, with no changes requested. This extension is set to expire on March 31, 2026.
The National Institute on Minority Health and Health Disparities announces a partially closed meeting to discuss health disparities affecting minority populations. This meeting aims to address ongoing challenges and strategies in health equity.
The National Institute of General Medical Sciences has announced a partially closed meeting, which may impact future funding and research directions. Details on the agenda and outcomes are yet to be disclosed.
The CDC announces a public meeting for the Subcommittee on Procedures Reviews of the Advisory Board on Radiation and Worker Health. While there is no public comment period, written comments can be submitted in advance.
The CDC reports an ongoing Salmonella outbreak linked to raw oysters, with 64 cases across 22 states. This highlights the need for increased awareness and food safety measures.
The proposed GLOBE Model aims to test a new Medicare payment approach for Part B drugs, potentially reducing costs for beneficiaries and the Medicare program. This initiative could reshape drug pricing strategies under the Social Security Act.
The proposed GUARD Model aims to test a new Medicare payment method for calculating inflation rebates on certain Part D drugs, potentially reducing costs for the Medicare program. This initiative could significantly impact drug pricing strategies and access for beneficiaries.
Proposed rules aim to enhance price transparency for non-grandfathered group health plans and individual health insurance coverage. This initiative seeks to standardize and improve the accuracy and accessibility of pricing information, impacting millions of consumers.
The HHS Office of the Deputy Secretary has issued a Request for Information to gather public input on accelerating the adoption of artificial intelligence in clinical care. This initiative aims to enhance the integration of AI technologies in healthcare settings.
The Eunice Kennedy Shriver National Institute of Child Health and Human Development is considering granting an exclusive patent license to EnZeta Immunotherapies, Inc. for innovations related to T cell enhancements. This move could bolster EnZeta's capabilities in developing immunotherapies targeting tumor reactivity.
The FDA has released final guidance on formal dispute resolution and administrative hearings under Section 505G of the Federal Food, Drug, and Cosmetic Act. This guidance aims to clarify procedures for resolving scientific and medical disputes between the FDA and industry stakeholders.
The NIH is seeking public comment on proposed data collection for Loan Repayment Programs, as mandated by the Paperwork Reduction Act. This initiative aims to enhance transparency and gather feedback before submission to the Office of Management and Budget.
The National Cancer Institute (NCI) is seeking public comment on the Clinical Trials Reporting Program (CTRP) database as part of compliance with the Paperwork Reduction Act. This initiative aims to enhance transparency in clinical trial data collection.
The HHS Secretary has accepted the recommendation to add Duchenne Muscular Dystrophy (DMD) to the Recommended Uniform Screening Panel (RUSP), following public comments and evidence-based reports. This decision could enhance early detection and intervention for DMD, impacting patient outcomes significantly.
The Health Resources and Services Administration has recommended adding Metachromatic Leukodystrophy (MLD) to the Recommended Uniform Screening Panel, a significant step in early detection. This decision follows public comments and evidence-based reports, with the Secretary of Health and Human Services accepting the recommendation.
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