Showing 1921-1930 of 2150 results for "".
- 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
- Alcon Announces European Launch of Vivity Presbyopia-Correcting IOL With X-WAVE Technologyhttps://modernod.com/news/alcon-announces-european-launch-of-vivity-presbyopia-correcting-iol-with-x-wave-technology/2477377/Alcon announced that the AcrySof IQ Vivity IOL is now commercially available in select European markets, with additional countries to follow throughout 2020. The latest innovation in Alcon’s portfolio of presbyopia-correcting IOLs (PC-IOLs), Vivity is the first-of-its-kind, extended range
- Analysts Give Gilead’s Remdesivir 50% Chance of Success as COVID-19 Treatmenthttps://modernod.com/news/analysts-give-gileads-remdesivir-50-chance-of-success-as-covid-19-treatment/2477362/Analysts at RBC Capital Markets suggested that it is a toss-up whether Gilead Sciences’ remdesivir will succeed in demonstrating efficacy and ultimately securing approval to treat COVID-19, citing limited dosing results, confounding data and previous disappointments in Ebola. “[The] b
- Two Chicago Ophthalmology Practices Receive Strategic Investment From MoonSail Capital And Plenary Partnershttps://modernod.com/news/two-chicago-ophthalmology-practices-receive-strategic-investment-from-moonsail-capital-and-plenary-partners/2477329/Chicago Eye Institute and Arbor Centers for EyeCare, two ophthalmology practices serving the Chicago market, announced that they have entered into a strategic partnership with private investment firms MoonSail Capital and Plenary Partners to form Ocular Partners.<
- Aldeyra Therapeutics to Provide Update on Late-Stage Clinical Development Pipeline at 2020 Research & Development Dayhttps://modernod.com/news/aldeyra-therapeutics-to-provide-update-on-late-stage-clinical-development-pipeline-at-2020-research-development-day/2477322/Aldeyra Therapeutics on Monday hosted the 2020 Research & Development Day (R&D Day) with investors and financial analysts in New York City to present recent clinical development updates and market opportun
- FDA Approves CooperVision Biofinity Toric Multifocal Contact Lenseshttps://modernod.com/news/fda-approves-coopervision-biofinity-toric-multifocal-contact-lenses/2477277/The FDA has granted CooperVision approval for its new Biofinity toric multifocal contact lenses. The product combines the optical designs of CooperVision’s Biofinity toric—the most prescribed toric lens on the market1—and Biofinity multifocal to provide patients with astigmatism and pr