FDA says Pfizer is expanding its Chantix recall and Apotex can temporarily distribute some of its generic Chantix product in the U.S. with levels of a...
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 approves Mercks Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease caused by 15 Strept...
FDA accepts for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters.
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...