Cetirizine ophthalmic solution 0.24% (Zerviate) is the first topical ocular formulation of the antihistamine for treatment of ocular itching associated with allergic conjunctivitis. FDA Approvals
Tag: News Alert
FDA Approves Tocilizumab (Actemra) for Giant Cell Arteritis
The FDA has expanded the approved use of subcutaneous tocilizumab (Actemra, Hoffman LaRoche) to include treatment of adults with giant cell arteritis. FDA Approvals
CHMP Backs Cenegermin (Oxervate) for Neurotrophic Keratitis
The CHMP has recommended granting marketing authorization for Oxervate for the treatment of adults with moderate or severe neurotrophic keratitis. International Approvals
FDA: Fluoroquinolones Not Linked to Retinal Detachment
Available evidence does not support reports that fluoroquinolone antibiotics may result in retinal detachment or aortic aneurysm or dissection, the FDA said. News Alerts
FDA OKs Ranibizumab for All Forms of Diabetic Retinopathy
The VEFG inhibitor had been approved just for diabetic retinopathy accompanied by diabetic macular edema, in addition to other eye disorders. FDA Approvals
FDA Clears New Corrective Intraocular Lens From Alcon
The AcrySof IQ ReSTOR +3.0D Multifocal Toric IOL corrects presbyopia and pre-existing corneal astigmatism at the time of cataract surgery in adults. FDA Approvals
FDA Clears Ranibizumab for Myopic Choroidal Neovascularization
Ranibizumab becomes the first FDA-approved anti-vascular endothelial growth factor therapy for mCNV. FDA Approvals
False Positives Common With LabCorp Zika Testing, FDA Warns
The ZIKV Detect test for virus antibodies always requires confirmation. A higher-than-expected rate of false positives underlines the need for double-checking. News Alerts
It’s Final: FDA Bans Powdered Gloves in Surgery, Medicine
The move follows efforts already underway to switch to safer alternative gloves for surgical use and in patient examinations. News Alerts
Texas Reports Local Zika Case, First Outside Florida
The Texas health department believes that a woman became infected from the bite of a local mosquito. Medscape Medical News
FDA Clears Ranibizumab Injection in a Prefilled Syringe
Lucentis PFS is the first syringe prefilled with a vascular endothelial growth factor inhibitor approved to treat wet AMD and macular edema after retinal vein occlusion. FDA Approvals
Mercaptamine Gets CHMP Nod for Corneal Deposits in Cystinosis
Cystadrops reduces corneal cystine crystal accumulation and is indicated in adults and children aged 2 years and older with cystinosis. International Approvals
CDC More Cautious on Conception, Sex After Zika Exposure
Men who’ve possibly been exposed to the virus without developing symptoms should wait much longer than previously advised to attempt pregnancy with a partner or have condomless sex. News Alerts
FDA Approves VisuMax Femtosecond Laser to Treat Myopia
The laser is used in small-incision lenticule extraction to reshape the cornea and reduce or eliminate nearsightedness. FDA Approvals
New MACRA Rules Make Medicare Pay Cut in 2019 Less Likely
Physicians can pick their own pace of implementation in 2017 to avoid a penalty, CMS acting administrator Andy Slavitt promised today. Medscape Medical News
Second Zika Zone in Florida Prompts CDC Travel Warning
Pregnant women shouldn’t visit a stretch of Miami Beach where mosquitos are spreading Zika, the CDC said. And pregnant women worried about the virus may consider postponing nonessential travel to all of Miami-Dade County. News Alerts
Local Transmission of Zika Likely Occurring in Florida
Four infected individuals represent the first instances of local transmission of the virus in the continental United States. The CDC expects to see more such cases here. News Alerts
Tecnis Symfony Intraocular Lens Wins FDA Approval
The new full-range intraocular lens (IOL), the first of its kind, improves on multifocal IOLs by reducing halos and glare. FDA Approvals
FDA Approves Lifitegrast (Xiidra) for Dry Eye
Lifitegrast ophthalmic solution 5% (Xiidra) is indicated for the treatment of signs and symptoms of dry eye disease in adults. FDA Approvals
FDA Clears Adalimumab (Humira) for Uveitis
The approval of adalimumab for noninfectious intermediate and posterior uveitis and panuveitis marks the 10th approved indication for adalimumab in the United States. FDA Approvals