Showing 1481-1490 of 1614 results for "".
- Novartis Provides Update On Use and Safety of Beovu (brolucizumab)https://modernod.com/news/novartis-provides-update-on-use-and-safety-of-beovu-brolucizumab/2477873/An internal review of post-marketing safety case reports of brolucizumab (Beovu; Novartis) has confirmed a rare occurrence of intraocular inflammation (IOI) in association with retinal vasculitis and retinal vascular occlusion. Following FDA approval of Beovu in October 2019, Novartis rece
- BVI Expands Portfolio with New Viscoelastic; Forges Strategic Partnership with Cromahttps://modernod.com/news/bvi-expands-portfolio-with-new-viscoelastic-forges-strategic-partnership-with-croma/2477789/BVI announced it has acquired the ophthalmic viscoelastic device (OVD) assets from Austrian-based Croma. In addition to the acquisition of existing products, BVI and Croma have embarked on an R&D collaboration on additional products that will come to market. Terms of the deal were not
- AMA Issues Guidance to Physicians on Using COVID-19 Antibody Testshttps://modernod.com/news/ama-issues-guidance-to-physicians-on-using-covid-19-antibody-tests/2477783/As new serology tests for COVID-19 rapidly come to the market, the American Medical Association (AMA) is cautioning physicians about using these tests to make healthcare decisions for individual patients, according to a FierceHealthcare
- Report: More Than Half of All Age-Related Macular Degeneration Cases Go Undiagnosedhttps://modernod.com/news/report-more-than-half-of-all-age-related-macular-degeneration-cases-go-undiagnosed/2477776/In the nine major pharmaceutical markets, less than half of age-related macular degeneration (AMD) cases were diagnosed in 2019 in adults aged 50 years and older, according to analytics company GlobalData. The company’s latest report, ‘
- FDA Approves Quidel’s Sofia 2, First Antigen Test to Help in the Rapid Detection of COVID-19https://modernod.com/news/quidel-receives-emergency-authorization-for-rapid-antigen-covid-19-diagnostic-assay/2477735/Quidel, which makes diagnostic tests for a variety of conditions including acute conjunctivitis and dry eye disease, announced that it has received Emergency Use Authorization (EUA) from the FDA to market its Sofia 2
- FDA Increases Oversight, Requirements for COVID-19 Antibody Testshttps://modernod.com/news/fda-increases-oversight-requirements-for-covid-19-antibody-tests/2477723/After allowing unreviewed antibody tests to pervade the U.S. market for weeks, the FDA is closing its open-door policy for coronavirus blood serology tests—bringing their oversight more in line with the molecular diagnostics used to confirm active cases of COVID-19, according to a Fierc
- Congress Urges FDA to Better Police, Evaluate COVID-19 Antibody Testshttps://modernod.com/news/congress-urges-fda-to-better-police-evaluate-covid-19-antibody-tests/2477665/Members of Congress have called on the FDA to re-evaluate its stance toward COVID-19 antibody tests. Since mid-March, the agency has allowed diagnostic developers to bring their products to market without any outside evaluation that the results they produce are accurate, according to a
- ‘A Disaster’: Roche CEO’s Verdict on Some COVID-19 Antibody Testshttps://modernod.com/news/a-disaster-roche-ceos-verdict-on-some-covid-19-antibody-tests/2477636/Some blood tests being marketed to tell people if they have had the new coronavirus are a “disaster,” Roche Chief Executive Severin Schwan said on Wednesday as he prepares to launch the drugmaker’s own antibody test next month, according to a Reuters report. </
- FDA Calls for Withdrawal of Ranitidine Products as Review Finds Contaminant Could Pose Riskhttps://modernod.com/news/fda-calls-for-withdrawal-of-ranitidine-products-as-review-finds-contaminant-could-pose-risk/2477519/The FDA requested that manufacturers immediately pull all prescription and over-the-counter (OTC) ranitidine drugs from the market, saying new evidence indicates users could be exposed to “unacceptable levels” of the probable carcinogen N-nitrosodimethylamine (NDMA) over time under ce
- Quidel Receives Emergency Use Authorization for Molecular COVID-19 Diagnostic Assayhttps://modernod.com/news/quidel-receives-emergency-use-authorization-for-molecular-covid-19-diagnostic-assay/2477407/Quidel, a provider of rapid diagnostic testing solutions, announced that the company has received Emergency Use Authorization (EUA) from the FDA to market its Lyra SARS-CoV-2 Assay, a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal or