Ortho Regenerative Technologies says it has submitted information requested by FDA to resolve a clinical hold on the Ortho-R drug/biologic combination...
FDA acting commissioner Janet Woodcock says that beginning this month, FDA started transitioning back to standard operations for domestic inspections.
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...
Ardelyx says FDA found deficiencies in the NDA review for tenapanor that preclude discussion of labeling and post-marketing requirements/commitments a...