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Ardelyx Tenapanor NDA Hits FDA Snag
[251 Words]
[ Price : $8.95]
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| Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requirements/commitments at this time. |
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07/19/2021
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FDA Approves Merck’s Pneumococcal Vaccine
[133 Words]
[ Price : $8.95]
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| FDA approves Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease caused by 15 Streptococcus pneumoniae serotypes. |
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07/19/2021
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FDA Accepts Aquestive NDA Resubmission
[180 Words]
[ Price : $8.95]
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| FDA accepts for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters. |
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07/19/2021
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Expanded Use of Prograf Relied on RWE
[292 Words]
[ Price : $8.95]
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| FDA approves a new use for Astellas Pharma’s Prograf (tacrolimus), based on real-world, for use in combination with other immunosuppressant drugs to prevent organ rejection in lung transplantation patients. |
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07/19/2021
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Shift to Include Pregnant Women in Trials: FDA
[481 Words]
[ Price : $8.95]
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| FDA pushes for a “major paradigm shift” to move the clinical development community from “systemic exclusion to the inclusion” of pregnant and breastfeeding women in clinical studies. |
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07/19/2021
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Aortic Aneurysm Device is ‘Breakthrough’
[98 Words]
[ Price : $8.95]
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| FDA grants Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascular abdominal aortic aneurysm sealing therapy. |
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07/19/2021
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Pfizer Covid Vaccine BLA Decision Due 1/2022
[205 Words]
[ Price : $8.95]
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| FDA grants Pfizer/BioNTech a priority review (user fee action due 1/2022) for a BLA for their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. |
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07/16/2021
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KorvaLabs Covid Test EUA Revoked
[135 Words]
[ Price : $8.95]
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| KorvaLabs requests that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now using different EUA-authorized tests for the testing offered at its laboratories. |
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07/16/2021
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