Rivaroxaban Plus Aspirin Beneficial in Symptomatic PAD After Revascularization
Xarelto, a Factor Xa inhibitor, is currently indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
Xarelto, a Factor Xa inhibitor, is currently indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The FDA has approved the New Drug Application for Triferic AVNU®.
The FDA has approved the supplemental Biologics License Application (sBLA) for Taltz (ixekizumab: Lilly) injection for the treatment of pediatric patients aged ≥6 years with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The FDA has accepted the resubmitted New Drug Application (NDA) for XaraColl® (bupivacaine hydrochloride collagen-matrix implants; Innocoll Holdings Limited) for the management of postsurgical pain after open inguinal hernia surgery.
Dr. Reddy’s Laboratories announced the voluntary recall of 4 lots of Phytonadione Injectable Emulsion 10mg/mL single-dose ampules to the hospital level due to ampules breaking and shattering, upon opening, during compounding.
The FDA has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.
The FDA has accepted for Priority Review the New Drug Application (NDA) for JZP-258 (Jazz Pharmaceuticals) for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients aged ≥7 years with narcolepsy.
Possible device malfunctions and use errors may delay or prevent treatment with EpiPen (epinephrine 0.3mg) and EpiPen Jr (epinephrine 0.15mg) autoinjectors, as well as the authorized generic versions.
Patients with spinal muscular atrophy (SMA) treated with a one-time infusion of onasemnogene abeparvovec-xioi (Zolgensma®;AveXis) continue to show clinically meaningful benefits even 5 years after dosing.
The FDA has granted Fast Track designation to PR006 (Prevail Therapeutics), an experimental gene therapy, to slow the progression of frontotemporal dementia with a GRN mutation.