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Pfizer Seeking EUA for ‘Promising ’ Covid Antiviral
[297 Words]
[ Price : $8.95]
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| Promising new data on its investigational Covid-19 oral antiviral agent Paxlovid PF prompts Pfizer to plan its early submission to the ongoing rolling submission seeking FDA Emergency Use Authorization. |
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11/05/2021
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ReWalk Robotics ‘Breakthrough’ on Home Exo-suit
[150 Words]
[ Price : $8.95]
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| FDA grants ReWalk Robotics a breakthrough device designation for its ReBoot, an exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries. |
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11/05/2021
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Panel Votes Down Prader-Willi Syndrome Drug
[171 Words]
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| An FDA advisory committee votes 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome did not show significant evidence of effectiveness. |
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11/05/2021
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FDA Approves Dyanavel XR ADHD Tablets
[83 Words]
[ Price : $8.95]
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| FDA approves a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorder in patients six years and older. |
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11/05/2021
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Pathogen Reduction in Blood Components Guide
[72 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Establishments: Questions and Answers. |
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11/04/2021
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Guide on Device Software Submissions
[75 Words]
[ Price : $8.95]
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| Federal Register notice: FDA makes available a draft guidance entitled Content of Premarket Submissions for Device Software Functions. |
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11/04/2021
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