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.
The Food and Drug Administration (FDA) has approved the use of Corlanor (ivabradine; Amgen) for the treatment of stable symptomatic heart failure (HF) due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.
The Food and Drug Administration (FDA) has granted Breakthrough Status designation to NightWare (NightWare, Inc.), a digital intervention therapy that measures and treats nightmares in patients with post traumatic stress disorder (PTSD).
The FDA has approved a revised product label for Octaplas (Octapharma), Pooled Plasma (Human), Solvent/Detergent Treated Solution for Intravenous Infusion.
