US WorldMeds announced that the Food and Drug Administration (FDA) has approved the reintroduction of Zelnorm (tegaserod) for the treatment of irritable bowel syndrome with constipation (IBS-C) in women aged <65 years.
The designation is given to potentially expedite development and review timelines for promising therapies.
Compared to placebo, treatment with ustekinumab resulted in a significantly greater proportion of adults with moderate to severe UC achieving clinical remission at week 44 (primary endpoint).
ViiV Healthcare announced positive 48-week data from the phase 3 ATLAS (N=616) and FLAIR (N=566) studies evaluating a long-acting injectable formulation of cabotegravir + rilpivirine in patients with HIV-1 infection.
The FDA has granted marketing clearance for eNeura’s single-pulse transcranial magnetic stimulation (sTMS) device for use in patients ≥12 years for the acute and prophylactic treatment of migraine.
