Individuals treated preventively with Xofluza were significantly less likely to develop influenza after exposure to an infected household member, according to data from the phase 3 BLOCKSTONE study.
Genentech announced positive topline data from two phase 3 trials, POLYP 1 and POLYP 2, evaluating Xolair (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to intranasal corticosteroids.
The FDA has sent an untitled letter to R3 Stem Cell, LLC of Scottsdale, Arizona for marketing unapproved stem cell products to treat a variety of diseases and conditions.
The FDA has approved a supplemental New Drug Application (sNDA) to update the product labeling for Xospata (gilteritinib; Astellas Pharma) to include final analysis data from the ADMIRAL trial demonstrating improvement in overall survival (OS).
The KALM-1 trial was a multicenter, double-blind, placebo-controlled 12-week study with a 52-week open label extension phase that evaluated the safety and efficacy of Korsuva injection in 350 hemodialysis patients
A phase 3 study assessing the use pregabalin as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint to reduce seizure frequency compared with placebo, according to Pfizer. The 12-week randomized, double-blind, placebo-controlled, multicenter study was conducted at 70 sites in…
The Food and Drug Administration (FDA) has approved Revlimid (lenalidomide; Celgene) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL). The approval was based on the randomized, double-blind, phase 3 AUGMENT study that evaluated the efficacy and safety of Revlimid…
Selective estrogen receptor modulators (SERMs) may be effective for treating male infertility, according to a recent systematic review and meta-analysis published in Expert Opinion on Pharmacotherapy. SERMs are compounds that exhibit tissue-selective estrogen receptor agonist and antagonist activity. Clomiphene citrate and tamoxifen are two agents commonly used for the off-label management of male infertility. To…
The FDA has approved the use of Vraylar (cariprazine; Allergan) to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults.
The FDA has approved Zolgensma (onasemnogene abeparvovac-xioi; Novartis) for the treatment of children less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
