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