FDA gives breakthrough therapy designation to rituxan for treatment of pemphigus vulgaris and is indicated for treating rheumatoid arthritis
All articles by Lea Eslava-Kim, PharmD
New opioid analgesic, NKTR-181, being evaluated in the SUMMIT-07 Phase 3 study for the treatment of moderate to severe chronic pain.
The regulator expects a decision on the new drug application by early autumn.
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.
Preliminary data from a phase 3 trial evaluating the safety and efficacy of a new sublingual formulation of cyclobenzaprine HCl for the treatment of fibromyalgia has been released.
The US FDA has granted Orphan Drug designation to dusquetide for the treatment of macrophage activation syndrome.
Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
Results were announced from a phase 3 trials assessing safety and efficacy of tofacitinib citrate for active psoriatic arthritis