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Acclarent, Inc., announced the US availability of the Acclarent Aera Eustachian Tube Balloon Dilation System, a balloon dilation intervention approved by the FDA for Eustachian Tube Dysfunction (ETD). Acclarent Aera is the only balloon dilation device that offers a minimally invasive option to treat the source of ETD, a condition often marked by ear pain, pressure, and dulled hearing.
Learn more about the Aera Eustachian Tube Balloon Dilation System
Amgen announced that the FDA approved Amjevita (adalimumab-atto) across all eligible indications of the reference product, Humira (adalimumab). Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, moderate-to-severe chronic plaque psoriasis, adult moderate-to-severe Crohn's disease and moderate-to-severe ulcerative colitis.
Learn more about Amjevita
Sarepta Therapeutics, Inc. announced that the FDA granted accelerated approval for Exondys 51 (eteplirsen) as a once-weekly intravenous infusion of 30 milligrams per kilogram for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.
Learn more about Exondys 51
Medtronic announced it received FDA approval of its MiniMed 670G system—the first Hybrid Closed Loop insulin delivery system approved anywhere in the world. The system is approved for the treatment of people with type 1 diabetes fourteen years of age and older with ongoing studies to expand the indication to additional patient populations. Medtronic will begin commercial release of the MiniMed 670G system in the spring of 2017 with system availability increasing over time.
Learn more about the MiniMed 670G system
The Medical Technology Business Group of Zeiss announced the US introduction of the VisuMax Small Incision Lenticule Extraction (SMILE) procedure, the latest advancement in refractive surgery for the correction of myopia. SMILE, a minimally-invasive corneal refractive procedure, performed on the Zeiss VisuMax femtosecond laser, is currently available in approximately 500 clinics in 61 countries around the world.
Learn more about the VisuMax SMILE procedure
Novartis announced that the FDA granted three simultaneous approvals for the expanded use of Ilaris (canakinumab) to treat three rare and distinct types of periodic fever syndromes. Ilaris is a biologic treatment for patients with tumor necrosis factor receptor-associated periodic syndrome, hyperimmunoglobulin D syndrome/mevalonate kinase deficiency and familial Mediterranean fever. All three conditions are part of a group of rare autoinflammatory diseases called periodic fever syndromes, which are also referred to as hereditary periodic fevers. Ilaris is already approved and marketed in the US as an effective and well-tolerated treatment for another periodic fever syndrome condition—cryopyrin-associated periodic syndromes, and another autoinflammatory condition—systemic juvenile idiopathic arthritis.
Learn more about Ilaris
The FDA modified the dosage regimen for nivolumab (Opdivo, Bristol-Myers Squibb Co.) for the currently approved indications for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer. The currently approved recommended dosage regimens were modified to 240mg IV every 2 weeks. In addition, the nivolumab dosing regimen in combination with ipilimumab for melanoma will remain the same (nivolumab 1mg/kg IV, followed by ipilimumab on the same day, every 3 weeks for 4 doses). However, after completion of ipilimumab, the recommended nivolumab dose will be 240mg every 2 weeks until disease progression or intolerable toxicity. The recommended dose for classical Hodgkin lymphoma remains 3mg/kg IV, every 2 weeks until disease progression or intolerable toxicity.
Learn more about Opdivo
Baxter International Inc. announced it is voluntarily recalling all unexpired lots of 50mm 0.2 micron filters (product code H93835, expiration 6/27/2016 – 6/27/2019) due to the potential for a missing filter support membrane and for potential presence of particulate matter. These issues are associated with a component manufactured by an external supplier, and were identified prior to patient involvement as a result of complaints from customers at compounding facilities.
Learn more about 50mm 0.2 micron filters
United Exchange Corp. of Cerritos, CA is voluntarily recalling products due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Learn more about eye wash/eye irrigation solutions
United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight-threatening eye infection.
Learn more about Family Care Eye Wash
Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the US due to two customer complaints from the UK and Portugal involving detached needles on the syringe with sterile water for injection. A syringe with a detached needle cannot be used as prescribed. The GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia in patients with diabetes who are treated with insulin.
Learn more about the GlucaGen HypoKit
Virtus Pharmaceuticals Opco II, LLC is voluntarily recalling seven batches of hyoscyamine sulfate (0.125mg) to the consumer level, which include the tablet, sublingual, and orally disintegrating tablet forms. This recall is being initiated due to both superpotent and subpotent test results.
Learn more about hyoscyamine sulfate 0.125mg
Nurse Assist announced voluntary
recall of all unexpired lots of I.V. Flush Syringes due to a potential link to Burkholderia cepacia bloodstream infections with the
product. According to the CDC, the effects of Burkholderia
cepacia on people “vary widely, ranging from no symptoms at all to
serious respiratory infections, especially in patients with cystic fibrosis.”
Nurse Assist voluntarily recalled its I.V. Flush Syringes after becoming aware
of patients that developed Burkholderia cepacia
bloodstream infections while receiving intravenous care using prepackaged
saline flushes from Nurse Assist.
Learn more about I.V. Flush Syringes
DePuy Synthes is recalling the Adaptor and Light Adaptor for their Small Battery Drive and Small Battery Drive II due to a potential for the adaptors to produce extreme internal pressure, which may cause the device to explode. The use of affected products may cause serious adverse health consequences, including death.
Learn more about the Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor
Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance.
Learn more about the sterile products by Wells Pharmacy Network
Vascular Solutions, Inc., initiated a nationwide recall of Twin-Pass Dual Access catheters used in catheterization procedures. All unexpired lots of the product have been recalled because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death. No injuries have been reported in association with this issue to date.
Learn more about the Twin-Pass Dual Access catheters
The FDA is warning consumers that homeopathic teething tablets and gels may pose a risk to infants and children. The FDA is analyzing adverse events reported to the agency regarding homeopathic teething tablets and gels, including seizures in infants and children who were given these products, since a 2010 safety alert about homeopathic teething tablets. The FDA is currently investigating this issue, including testing product samples.
Learn more about homeopathic teething tablets and gels
The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. The FDA believes that women at high risk for developing ovarian cancer should not use any currently offered test that claims to screen for ovarian cancer.
Learn more about ovarian cancer screening tests