The new approval is accelerated and is therefore conditional upon further proof of efficacy, but the checkpoint inhibitor becomes the first approved option in advanced SCLC in a long time. FDA Approvals
The Brainsway deep transcranial magnetic stimulation system is an option for patients with obsessive-compulsive disorder (OCD) who have not responded to traditional treatments. FDA Approvals
Cequa is a patented, novel, proprietary nanomicellar formulation of cyclosporine A in a clear, preservative-free, aqueous solution. FDA Approvals
The letter to healthcare providers was issued after the agency reviewed final results of a postmarket study conducted by the device maker, SynCardia Systems. News Alerts
A new study finds unique differences in survival but also raises questions about how best to classify these patients and why so many have no identifiable triggering event. Medscape Medical News
The Foundation 3D anterior lumbar interbody cage implant uses CoreLink’s proprietary mimetic metal technology, which mimics key characteristics of natural bone. FDA Approvals
The dean of New York University School of Medicine calls it a ‘moral imperative’ to help students who want to become physicians do so without facing crushing debt. News Alerts
Teva Pharmaceuticals USA gained approval to market its generic epinephrine autoinjector in 0.3-mg and 0.15-mg strengths. FDA Approvals
The oral therapy lenvatinib joins sorafenib as the only drugs approved for first-line treatment of patients with unresectable hepatocellular carcinoma. FDA Approvals
The system is the only percutaneous PNS system cleared by the FDA and is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain. FDA Approvals
A large study provides the first biomarker evidence that maternal exposure to the pesticide DDT may raise the risk for autism in offspring. News Alerts
The Hydrus microstent used in conjunction with cataract surgery achieves significant and sustained lowering of intraocular pressure in patients with primary open-angle glaucoma. FDA Approvals
The combined levothyroxine (T4) and liothyronine (T3) thyroid tablets from Westminster Pharmaceuticals are being recalled to the wholesale level as a precaution because of a risk of adulteration. News Alerts
Migalastat (Galafold) is for adults with Fabry disease who have a genetic mutation amenable to treatment based on laboratory data. FDA Approvals
The "fertility awareness" app, called Natural Cycles, calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information. FDA Approvals
Annovera (segesterone acetate and ethinyl estradiol vaginal system) is the first vaginal ring contraceptive approved that provides a full year of protection against unintended pregnancy. FDA Approvals
Patisiran is the first FDA-approved treatment for polyneuropathy caused by hATTR and the first RNA-based therapy to treat a rare disease. FDA Approvals
The FDA is concerned about misuse and overreliance of rupture of amniotic membrane lab test results without other clinical assessments to make patient management decisions, which could lead to serious harm. News Alerts
The lumacaftor/ivacaftor combination drug is now approved for children aged 2 to 5 years who have two copies of the F508del mutation in the CTFR gene. FDA Approvals
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