FDA clears GE Healthcares Critical Care Suite 2.1 that includes a pneumothorax algorithm.
FDA grants Arcturus Therapeutics an orphan drug designation for ARCT-032 and its use to treat cystic fibrosis.
Federal Register notices: FDA publishes notices about the regulatory review period determinations for eight drug products sponsored by KemPharm, Apell...
FDA accepts for review a Karuna Therapeutics NDA for KarXT (xanomeline-trospium) for treating schizophrenia in adults.
Stakeholders comment positively on an FDA draft guidance on developing products to prevent or treat graft-versus-host disease.
A CDER study examines generic nasal spray distribution factors that could speed the development of generic sprays.
FDA clears a Vivos Therapeutics 510(k) for its Vivos CARE (Complete Airway Repositioning and/or Expansion) appliances for treating adults with severe ...
FDA continues to evaluate information about the potential for differences in procedural outcomes between women and men undergoing implant of a left at...
