A new biosimilars report says that FDA has approved a total of 73 biosimilars across 19 unique biological molecules, and so far only 48 (66%) of these...
Axios reports that key FDA databases that are relied on by healthcare professionals are not being fully updated due to staff shortages resulting from ...
FDA approves an Akeso Biopharma BLA for penpulimab-kcqx, indicated for adults with recurrent or metastatic non-keratinizing nasopharyngeal carcinoma.
FDA awards BrainChild Bio a breakthrough therapy designation for its investigational CAR T-cell therapy, BCB-276, for treating a rare and fatal pediat...
Amneal Pharmaceutical recalls two lots of ropivacaine hydrochloride injection USP, 500 mg/100 mL, infusion bags because the products may contain an in...
FDA alerts health care providers about reports of falsely elevated results associated with ASP Globals RAM Scientific SAFE-T-FILL Micro Capillary Bloo...
FDA warns Houston, TX-based Empower Pharma about multiple violations in its production of unapproved and misbranded compounded drugs.
The DC federal court throws out Norwichs suit seeking to force FDA to find that Actavis has forfeited its exclusivity for a generic form of rifaximin ...
