Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for: - Treatment in monotherapy of infantile spasms (West's syndrome). - Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
The FDA has accepted a new drug application (NDA) seeking the approval of ensartinib (X-396) for the treatment of adult patients with metastatic ALK-positive non–small cell lung cancer (NSCLC), according to an announcement from Xcovery Holdings
Italfarmaco S.p.A. announced that the FDA has approved Duvyzat (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of patients 6 years or older with Duchenne muscular dystrophy (DMD), a rare X-linked progressive and life-limiting neuromuscular condition with symptoms from early childhood.
Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo.
This study was for women in menopause with hot flashes. Menopause, a normal part of aging, was the time of a woman's last period. Hot flashes can interrupt a woman's daily life.