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TXT Ardelyx Tenapanor NDA Hits FDA Snag [251 Words] [ Price : $8.95]
Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requirements/commitments at this time.
07/19/2021
 
 
TXT Nevro OK’d for Treating Diabetic Neuropathy [92 Words] [ Price : $8.95]
FDA approves a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy.
07/19/2021
 
 
TXT FDA Approves Merck’s Pneumococcal Vaccine [133 Words] [ Price : $8.95]
FDA approves Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease caused by 15 Streptococcus pneumoniae serotypes.
07/19/2021
 
 
TXT FDA Accepts Aquestive NDA Resubmission [180 Words] [ Price : $8.95]
FDA accepts for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters.
07/19/2021
 
 
TXT Expanded Use of Prograf Relied on RWE [292 Words] [ Price : $8.95]
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.
07/19/2021
 
 
TXT Shift to Include Pregnant Women in Trials: FDA [481 Words] [ Price : $8.95]
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.
07/19/2021
 
 
TXT Aortic Aneurysm Device is ‘Breakthrough’ [98 Words] [ Price : $8.95]
FDA grants Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascular abdominal aortic aneurysm sealing therapy.
07/19/2021
 
 
TXT Latest Federal Register Notices [1498 Words] [ Price : $8.95]
FDA Review posts the Federal Regiter notices for the week ending 7/16/2021.
07/18/2021
 
 
TXT Pfizer Covid Vaccine BLA Decision Due 1/2022 [205 Words] [ Price : $8.95]
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.
07/16/2021
 
 
TXT KorvaLabs Covid Test EUA Revoked [135 Words] [ Price : $8.95]
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.
07/16/2021
 
 
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