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BioWorld - Sunday, January 11, 2026
Home » Topics » Regulatory » NIH

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Concept art for adeno-associated viral-based gene therapy.
Drug Design, Drug Delivery & Technologies

New regulatory playbook to guide AAV gene therapy development for rare diseases

Feb. 7, 2024
The Foundation for the National Institutes of Health (FNIH) has announced the online publication of the first playbook designed to help accelerate the development of adeno-associated virus (AAV) gene therapies for rare diseases.
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Neurology illustration
Neurology/Psychiatric

NIH and DoD grants support Acurastem’s work in ALS and FTD

Jan. 31, 2024
Acurastem Inc. has raised nearly $7 million in grant funding from the National Institutes of Health (NIH) and the Department of Defense (DoD) to advance research in amyotrophic lateral sclerosis (ALS) and frontotemporal dementia.
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OIG: US NIH audit oversight puts federal funds at risk

Dec. 22, 2023
By Mari Serebrov
If two recent reports about the NIH’s oversight of its grant programs were grades, the U.S. agency would have received failing marks – again.
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Microscope with laptop displaying histology image.
Immuno-oncology

Replay and Syena license NIH library of TCRs targeting cancer neoantigens

Dec. 20, 2023
Replay Holdings LLC has entered into an exclusive, worldwide license agreement with the National Institutes of Health (NIH) for intellectual property related to a library of T-cell receptors (TCRs) directed against multiple cancer neoantigens.
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Silhouette with keyhole
Substance Use & Poisoning

Delix awarded NIDA grant to support development of neuroplastogen for substance use disorders

Dec. 14, 2023
Delix Therapeutics Inc. has been awarded a $320,000 grant from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to support the advancement of DLX-007.
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Monica Bertagnolli, NIH director

Bertagnolli confirmed as next US NIH director

Nov. 7, 2023
By Mari Serebrov
After nearly two years with an acting director, the U.S. NIH now has a confirmed leader. The Senate voted 62-36 Nov. 7 to confirm Monica Bertagnolli, a cancer surgeon and researcher, as the next director of the research agency.
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Gloved hand holding COVID-19 vaccine vial, syringe
Immune

NIAID selects Tonix’s COVID-19 vaccine candidate TNX-1800 for inclusion in Project Nextgen trials

Nov. 3, 2023
The National Institute of Allergy and Infectious Diseases (NIAID) is set to conduct a phase I trial with Tonix Pharmaceuticals Holding Corp.’s TNX-1800 (recombinant horsepox virus, live vaccine), a vaccine candidate to protect against COVID-19.
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Telehealth credited with boosting effectiveness of care for opioid-use disorder

Oct. 30, 2023
By Mark McCarty
Advocates of expanded use of telehealth in the U.S. may believe they have an unfairly high evidentiary bar to meet to bring payers on board, but that evidentiary requirement just received support from the National Institutes of Health (NIH).
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3D concept image of nanoparticle layers
Immuno-oncology

NCI grant supports development of Duo Oncology's DUO-307

Oct. 30, 2023
Duo Oncology Inc. has been awarded a Small Business Technology Transfer grant by the National Cancer Institute (NCI) to support the development of DUO-307, a combination nanomedicine that delivers cytotoxic polymer conjugated gemcitabine (PGEM) and an immune modulating chemokine receptor type 2 antagonist (CCR2a) to tumor tissue.
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Monica Bertagnolli, NIH director

Despite chair’s opposition, US NIH nominee gets HELPing hand

Oct. 25, 2023
By Mari Serebrov
After nearly two years with an unconfirmed acting director at its helm, the U.S. NIH is one step closer to finally having Senate-confirmed leadership to steer the agency in a time pressed with political agendas, pandemic concerns and the potential for what could be life-altering innovations. The Senate Health, Education, Labor and Pensions (HELP) Committee voted 15-6 Oct. 25 to favorably report Monica Bertagnolli’s nomination to the full Senate for a confirmation vote as the next NIH director.
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