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Home » Topics » Regulatory

Regulatory
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Cancer cell targeted in crosshairs
Immuno-oncology

Avstera’s AVS-100 cleared to enter clinic for solid tumors

Dec. 19, 2023
Avstera Therapeutics Corp. has received FDA clearance of its IND application for HDAC6 inhibitor AVS-100. Avstera intends to initiate a phase Ia/b trial in the first half of 2024 to evaluate AVS-100 alone and in combination with pembrolizumab in locally advanced or metastatic solid tumors.
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Urinary tract with kidneys, adrenalin glands, ureter and vessels on light blue background
Infection

NRX-101 receives FDA clearance to enter clinic for cUTI

Dec. 19, 2023
Nrx Pharmaceuticals Inc. has announced FDA clearance of its IND application for the use of NRX-101 (lurasidone hydrochloride/D-cycloserine) for the treatment of complicated urinary tract infections (cUTI).
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Manufacturing issues yield CRL for Checkpoint’s PD-L1 drug

Dec. 18, 2023
Shares of Checkpoint Therapeutics Inc. dropped 44.8% Dec. 18 on news that the U.S. FDA issued a complete response letter (CRL), delaying potential approval of PD-L1 antibody cosibelimab in metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA had accepted in March the BLA, seeking use for treating patients who are not candidates for curative surgery or radiation, setting a Jan. 3, 2024, PDUFA date.
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Top Trends Firsts, finish line flag

First CRISPR-based therapeutic is scientific, regulatory milestone

Dec. 18, 2023
By Anette Breindl
Both the U.K. MHRA and the U.S. FDA approved their first CRISPR-based gene therapy in 2023. Crispr Therapeutics AG and partner Vertex Pharmaceuticals Inc.’s Casgevy (exagamglogene autotemcel, exa-cel) was approved by the MHRA in November and the FDA on Dec. 8. The U.K. approval is for both severe sickle cell disease (SCD) and transfusion-dependent thalassemia (TDT). In the U.S., the approval is for severe SCD, with a PDUFA date for TDT coming up in spring 2024.
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Regulatory actions for Dec. 18, 2023

Dec. 18, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bioamerica, Masimo, Neuronetics, Tyber Medical, Fuse-AI.
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FDA icons and doctor

Neuroone’s ablation system for neurological disorders gets FDA greenlight

Dec. 18, 2023
By Shani Alexander
Neuroone Medical Technologies Corp. received U.S. FDA 510(k) clearance for its Onerf ablation system which is capable of both recording electrical activity and ablation of nervous tissue.
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Galleri instruction booklet on blood draw chair

Illumina concedes, plans to divest unholy Grail

Dec. 18, 2023
By Annette Boyle
After years of battling to retain its hold on Grail Inc., Illumina Inc. finally announced that it will be unwinding the ill-fated acquisition of the multi-cancer early detection test maker. In addition to stiff opposition from activist investor Carl Icahn that cost Illumina’s previous CEO and board chair their positions, European and U.S. regulators have consistently opposed the deal.
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Brain cancer illustration
Cancer

Neuexcell's NXL-004 gets US orphan status for malignant glioma

Dec. 18, 2023
Neuexcell Therapeutics Inc. has announced that NXL-004, an investigational AAV gene therapy product being developed for the treatment of malignant glioma, has been awarded orphan drug designation by the FDA.
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US Worldmeds nabs FDA nod for oral maintenance therapy for high-risk neuroblastoma

Dec. 15, 2023
By Jennifer Boggs
Following the recommendation of its Oncology Drugs Advisory Committee, the U.S. FDA approved U.S. Worldmeds LLC’s eflornithine 192-mg tablets for use as a maintenance therapy in patients with high-risk neuroblastoma. Branded Iwilfin, the specific, irreversible inhibitor of ornithine decarboxylase previously known as DFMO, is expected to be available in the coming weeks.
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FDA draft guidance for 510(k) clinical data draws fire

Dec. 15, 2023
By Mark McCarty
The FDA’s ongoing efforts to modernize the 510(k) program produced three draft guidances in the waning days of fiscal year 2023, one of which is a draft for the scenarios in which clinical data would be required for a 510(k) application.
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