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Oblato Announces that it has received a Positive Response from the FDA for the use of OKN-007 for patients with high-grade gliomas in an Expanded Access Program

Oblato Announces that it has received a Positive Response from the FDA for the use of OKN-007 for patients with high-grade gliomas in an Expanded Access Program
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United statesNew jerseyOblato incஒன்றுபட்டது மாநிலங்களில்புதியது ஜெர்சி

Oblato Announces Fast Track Designation of OKN-007 for Diffuse Intrinsic Pontine Glioma from the FDA

Share this article PRINCETON, N.J., March 3, 2021 /PRNewswire/ Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announces that the FDA granted Fast Track Designation of OKN-007, the proprietary drug for Diffuse Intrinsic Pontine Glioma (DIPG). The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. With the Fast Track Designation of OKN-007 for the treatment of DIPG, Oblato is eligible for Accelerated Approval and Priority Review and for Rolling Review that allows the Company to submit completed sections of its New Drug Application (NDA) for review by FDA before the entire application can be reviewed. The Company expects that the period of the regulatory approval process will be reduced.

United statesNew jerseyOblato incGtreebnt co ltdFast track designationDiffuse intrinsic pontine gliomaAccelerated approvalPriority reviewRolling reviewNew drug applicationRare pediatric diseaseஒன்றுபட்டது மாநிலங்களில்புதியது ஜெர்சிவேகமாக டிராக் பதவிமுடுக்கப்பட்ட ஒப்புதல்ப்ரையாரிடீ விமர்சனம்

Oblato Announces Fast Track Designation of OKN-007 for Diffuse Intrinsic Pontine Glioma from the FDA

Oblato Announces Fast Track Designation of OKN-007 for Diffuse Intrinsic Pontine Glioma from the FDA
prnewswire.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from prnewswire.com Daily Mail and Mail on Sunday newspapers.

United statesNew jerseyOblato incGtreebnt co ltdFast track designationDiffuse intrinsic pontine gliomaAccelerated approvalPriority reviewRolling reviewNew drug applicationRare pediatric diseaseஒன்றுபட்டது மாநிலங்களில்புதியது ஜெர்சிவேகமாக டிராக் பதவிமுடுக்கப்பட்ட ஒப்புதல்ப்ரையாரிடீ விமர்சனம்

Oblato Announces Discussion Outcome with FDA for Development of OKN-007 for Diffuse Intrinsic Pontine Glioma

Share: PRINCETON, N.J., Dec. 10, 2020 /PRNewswire/ Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007. Through this FDA meeting, the Company obtained consent from the FDA on important matters, such as patient population, starting dose, approach for dose escalation, and criteria for evaluating disease response. Importantly, there was in depth discussion on how to actively utilize existing historical patient data instead of requiring a comparative group in consideration of the nature of DIPG, a severe rare pediatric glioma and the need for all patients to receive anti-cancer treatment. The FDA also gave detailed advice on pharmacokinetic assessment and standard of care radiation

United statesNew jerseyOblato incPrnewswire oblato incGtreebnt co ltdDiffuse intrinsic pontine gliomaSarepta therapeuticsRare pediatric disease designationRare pediatric disease priority reviewஒன்றுபட்டது மாநிலங்களில்புதியது ஜெர்சிசாறெப்டா சிகிச்சைரேர் குழந்தை நோய் பதவிரேர் குழந்தை நோய் ப்ரையாரிடீ விமர்சனம்