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4 Ways to Reform FDA Drug Regulatory Reform
[2986 Words]
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| Former FDA principal deputy commissioner Joshua Sharfstein calls for reforms to the agency’s decades of drug regulation reform to increase the effectiveness and efficiency of the search for new therapies. |
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01/14/2020
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Personal Cancer Monitor Granted Breakthrough Status
[122 Words]
[ Price : $8.95]
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| FDA grants ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring and recurrence surveillance. |
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01/14/2020
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Republicans Reopen Opioid Manufacturer Probe
[2709 Words]
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| House Energy and Commerce Committee Republican leaders say they are renewing a 2018 investigation into three opioid manufacturers to get all the information and answers they are seeking. |
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01/14/2020
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FDA Alert on Eisai Weight-loss Drug
[100 Words]
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| A new FDA safety alert says that results from a clinical trial assessing safety of Eisai’s weight-loss drugs Belviq and Belviq XR (lorcaserin) show a possible increased cancer risk. |
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01/14/2020
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Partial Clinical Hold on Innate’s Lacutamab
[293 Words]
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| FDA places a partial clinical hold on Innate Pharma’s TELLOMAK Phase 2 trial that is evaluating lacutamab’s efficacy and safety in patients with advanced T-cell lymphomas. |
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01/14/2020
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sNDA for Lynparza Accepted for Review
[247 Words]
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| FDA accepts for priority review an AstraZeneca supplemental NDA for Lynparza (olaparib) in combination with bevacizumab for the maintenance treatment of certain women with advanced ovarian cancer. |
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01/13/2020
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Draft Guide on PTA/Specialty Catheters
[96 Words]
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| Federal Register notice: FDA makes available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” |
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01/13/2020
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Taro Recalls 1 Lot of Contaminated Lamotrigine
[127 Words]
[ Price : $8.95]
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| Taro Pharmaceuticals recalls one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a small amount of enalapril maleate. |
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01/13/2020
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