Clinical Datasets and Food and Drug Administration

Selected news for the healthcare topic - Clinical Datasets, and the healthcare topic - Food and Drug Administration. We have 11 shared news items for this connection to-date.

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Date Headline (link) Source Relevant Snippet
7/2/2020 The Law Offices of Frank R. Cruz Announces Investigation on Behalf of CytoDyn Inc. Investors (CYDY) | Business Wire Business Wire ... Food and Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients." Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab "will be considered completed after the clinical datasets are submitted on May 11, 2020." On this news, the Company's share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30 ...
7/1/2020 INVESTOR ALERT: Law Offices of Howard G. Smith Continues Investigation of CytoDyn Inc. (CYDY) on Behalf of Investors | Business Wire Business Wire ... Food and Drug Administration for Leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients." Then, on May 7, 2020, CytoDyn announced that its BLA for Leronlimab "will be considered completed after the clinical datasets are submitted on May 11, 2020." On this news, the Company's share price fell as much as $0.225, or more than 7%, during intraday trading on May 8, 2020. On June 30 ...
6/11/2020 CytoDyn Initiates Phase 2 Clinical Trial With Leronlimab for Treatment of NASH Other OTC:CYDY Globe Newswire ... suggests the potential of leronlimab to control both the early and late stages of NASH. There are currently no U.S. Food and Drug Administration (FDA) approved treatments for NASH and it is expected to be ... FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation ...
6/8/2020 CytoDyn Receives BLA Acknowledgment Letter From the FDA | Markets Insider Business Insider ... biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could ... FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation ...
6/8/2020 CytoDyn Receives BLA Acknowledgment Letter From the FDA Other OTC:CYDY Globe Newswire ... biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the U.S. Food and Drug Administration (FDA) advised the Company, subject to its ongoing review, it could ... FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the FDA deems a BLA submission complete, it sets a PDUFA goal date. CytoDyn has Fast Track designation ...
11/30/2019 Cytotron® Granted ‘Breakthrough Device Designation’ by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers ... Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD , ‘Breakthrough Device Designation’ for the CYTOTRON® – a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance ( Breakthrough Devices Program ), to enable the marketing submission, with the clinical datasets needed to support it,” said Prof. Meena Augustus , Co-Founder CEO & CSO ...
11/1/2019 Cytotron granted ‘breakthrough device designation’ by US FDA for treatment of breast, liver, and pancreatic cancers The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, ‘Breakthrough Device Designation’ for the CYTOTRON® – a CE marked, whole-body therapeutic medical device. “We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed ...
10/31/2019 Cytotron® Granted 'Breakthrough Device Designation' by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers PR Newswire ... Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD , 'Breakthrough Device Designation' for the CYTOTRON® - a CE marked, whole-body therapeutic medical device. "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance ( Breakthrough Devices Program ), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus , Co-Founder CEO & CSO ...
10/31/2019 Cytotron(R) Granted 'Breakthrough Device Designation' by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers ... Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD, 'Breakthrough Device Designation' for the CYTOTRON® - a CE marked, whole-body therapeutic medical device. "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO ...
10/31/2019 Cytotron® Granted 'Breakthrough Device Designation' by U.S. FDA for Treatment of Breast, Liver, and Pancreatic Cancers | BioSpace BioSpace ... Food and Drug Administration (FDA) granted Shreis Scalene Sciences (Shreis), in Gaithersburg, MD , 'Breakthrough Device Designation' for the CYTOTRON® - a CE marked, whole-body therapeutic medical device. "We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance ( Breakthrough Devices Program ), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus , Co-Founder CEO & CSO ...
10/21/2019 The FluPRINT dataset, a multidimensional analysis of the influenza vaccine imprint on the immune system Nature ... of a new seasonal influenza vaccine to prevent influenza-like illness compared to the placebo group, according to the US Food and Drug Administration (FDA) in their guideline for vaccine licensure 2 . Young children and ... elusive. The application of computational biology and machine learning to clinical datasets holds great promise for identifying immune cell populations and genes that mediate HAI antibody responses to influenza vaccines as a correlate of vaccine ...
4/29/2019 Finch Therapeutics Receives Fast Track Designation for the Investigation of Full-Spectrum Microbiota as a Treatment for Children with Autism Spectrum Disorder | Business & Finance | manchestertimes.com Business Wire ... BUSINESS WIRE)--Apr 29, 2019--Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its Full-Spectrum Microbiota ... RSM platform employs machine-learning algorithms to mine Finch’s unique clinical datasets, reverse engineering successful clinical experience to identify the key microbes driving patient outcomes. Finch has a strategic partnership with Takeda to develop FIN ...