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FDA approves a new use for Astellas Pharmas Prograf (tacrolimus), based on real-world, for use in combination with other immunosup...[ Price : $8.95]
FDA pushes for a major paradigm shift to move the clinical development community from systemic exclusion to the inclusion of pregn...[ Price : $8.95]
FDA grants Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascu...[ Price : $8.95]
Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requir...[ Price : $8.95]
FDA approves a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy.[ Price : $8.95]
FDA Review posts the Federal Regiter notices for the week ending 7/16/2021.[ 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 ...[ 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 u...