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December 28, 2021
Combination therapy with nivolumab plus ipilimumab conferred an OS benefit for patients with asymptomatic melanoma brain metastases, according to results of the open-label, phase 2 CheckMate 204 study published in The Lancet Oncology.“Immunotherapy in melanoma has been excessively studied ... (but) all of the phase 3 studies completely excluded patients with any evidence of brain
December 28, 2021
The American Thoracic Society published a new clinical practice guideline to aid physicians in the outpatient management of infants, children and adolescents with post-prematurity respiratory disease.“There was a pressing need for updated guidance for clinicians who treat these patients,” ATS panel co-chairs A. Ioana Cristea, MD, MS, associate professor of clinical pediatrics in the
December 27, 2021
People with schizophrenia spectrum disorders appeared to have increased risk for perpetrating violent outcomes compared with community control individuals, according to a systematic review and meta-analysis published in JAMA Psychiatry. “A previous systematic review identified 20 primary studies from 11 countries that reported a substantial increase in risk of violence perpetration in
December 25, 2021
The most-read FDA approval stories of 2021 include Tyrvaya nasal spray and Byooviz, the first ophthalmology biosimilar to receive FDA approval.Read more about the FDA approvals below.
December 23, 2021
The FDA issued final guidance for 510(k) submissions for arthroscopy pump tubing sets intended for multiple patient use. According to the FDA guidance document, 510(k) submissions should include a description of all device components integral to multiple patient use tubing sets. Illustrative schematics and/or engineering drawings of each device component are also recommended, as well as
December 23, 2021
A COVID-19 vaccine for young children is “unlikely” to be available before mid or even late 2022, an expert said.
December 23, 2021
SMILE proved effective in correcting residual myopia and myopic astigmatism in pseudophakic eyes, leading to significant visual acuity gain.In a poster presented at the American Academy of Ophthalmology meeting, Anita Syla Lokaj, MD, PhD, and co-authors showed the results of a retrospective study of patients from Kosovo and other countries.
December 23, 2021
The FDA approved insulin glargine-aglr, a second biosimilar to Sanofi’s insulin glargine, to improve glycemic response in children and adults with type 1 diabetes and adults with type 2 diabetes.Insulin glargine-aglr (Rezvoglar, Eli Lilly) is a long-acting insulin analog available as a 3 mL prefilled KwikPen, to be administered once daily, according to the package insert.
December 23, 2021
Use of hyaluronic acid injections significantly increased among Medicare beneficiaries for all providers from 2012 to 2018, with advanced practice providers largely contributing to the increase, according to published results.Researchers used the 2012 to 2018 Medicare Fee-for-Service Provider Utilization and Payment Public Use Files to collect payment and utilization data for all Healthcare
December 22, 2021
A select group of people who spend their day jobs fighting cancer — as surgical oncologists, radiation epidemiologists, or working in radiobiology and bionanotechnology — had a unique opportunity to lend their expertise to NASA.The Committee on Assessment of Strategies for Managing Cancer Risks Associated with Radiation Exposure During Crewed Space Missions included several experts