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...
CDER creates a new Center of Excellence for Quantitative Medicine to advance therapeutic medical product development and inform regulatory decision-ma...
FDA posts a notification about four information collections that have been approved by OMB.
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...
