Most Recent Articles by Diana Ernst, RPh
This investigational lentiviral-based gene therapy is currently being studied in the Phase 2/3 Starbeam Study, a 2-year study assessing the safety and efficacy of Lenti-D in boys ≤17 years old with CALD.
The Agency is urging manufacturers to stop marketing OTC oral drug products containing benzocaine for teething to this patient population.
The approval of Yonsa was based on 2 randomized, placebo-controlled, multicenter Phase 3 studies in patients with mCRPC.
The efficacy and safety of Prolia in the treatment of patients with glucocorticoid-induced osteoporosis was assessed in the 12-month primary analysis of a 2-year, randomized, multicenter, double-blind, parallel-group, active-controlled study (N=795).
The approval of Doptelet was based on results from the ADAPT-1 (N=231) and ADAPT-2 trials (N=204), 2 identically-designed multicenter, randomized, double-blind, placebo-controlled studies.