FDA warns Dr. Bret Rutherford about violations in his work as a clinical study investigator at the New York State Psychiatric Institute.
Mesoblast says it will refile its BLA for remestemcel-L for treating pediatric steroid-refractory acute graft versus host disease following favorable...
FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after ...
Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for...
Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chloride irrigation USP and...
FDA approves Johnson & Johnsons Opsynvi, a combination single tablet of macitentan and tadalafil for treating adults with pulmonary arterial hypertens...
FDA sends Regeneron Pharmaceuticals two complete response letters on its BLA for odronextamab in relapsed/refractory follicular lymphoma and in R/R di...
Following recent Congressional action giving FDA additional authorities, the agency is again proposing a rule to ban electrical stimulation devices in...
