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TXT 2 Former Immunomedics Officials Arrested [2772 Words] [ Price : $8.95]
The Justice Department says two former Immunomedics officials have been arrested on charges of insider trading.
12/02/2021
 
 
TXT CoreLink 510(k) Spinal Fixation System [109 Words] [ Price : $8.95]
FDA clears a CoreLink 510(k) for its CentraFix Midline Spinal Fixation System.
12/02/2021
 
 
TXT Sonar Software App Cleared for Respiration Measure [93 Words] [ Price : $8.95]
FDA clears a Sound Life Sciences 510(k) for its sonar software for consumer smart devices for measuring breathing.
12/02/2021
 
 
TXT FDA Withdraws 5 No-Longer Marketed ANDAs [73 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws approval of five ANDAs from multiple applicants because they are no longer marketed.
12/02/2021
 
 
TXT Merck sBLA for Pneumococcal Vaccine [185 Words] [ Price : $8.95]
FDA accepts for review a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for preventing invasive pneumococcal disease in children.
12/02/2021
 
 
TXT Complete Response Letter for Plinabulin [2677 Words] [ Price : $8.95]
FDA tells BeyondSpring Pharmaceuticals a second study is needed to demonstrate substantial benefit of its plinabulin in preventing chemotherapy-induced neutropenia.
12/01/2021
 
 
TXT Class 2 for Isocapnic Ventilation Devices [99 Words] [ Price : $8.95]
Federal Register notice: FDA classifies isocapnic ventilation devices into Class 2 (special controls), following a de novo classification request from Thornhill Research for its ClearMate device.
12/01/2021
 
 
TXT Info Collection on Investigator Financial Disclosures [53 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension entitled “Financial Disclosure by Clinical Investigators.”
12/01/2021
 
 
TXT FDA Patient Engagement Panel Renewal [65 Words] [ Price : $8.95]
Federal Register notice: FDA renews its Patient Engagement Advisory Committee for an additional two years beyond the charter expiration date.
12/01/2021
 
 
TXT FDA Approves Darzalex Faspro for Myeloma [2644 Words] [ Price : $8.95]
FDA approves Janssen’s Darzalex Faspro plus Kyprolis and dexamethasone to treat some multiple myelomas.
12/01/2021
 
 
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