FDA Approval In-Vitro Sales Trials 
XTalks
JUNE 26, 2023
Medical device and in vitro diagnostics technologies provider SurModic Inc. has announced that its new drug-coated balloon (DCB) SurVeil has been granted approval by the US Food and Drug Administration (FDA). The balloon is designed for the treatment of patients with peripheral artery disease.
The Pharma Data
AUGUST 16, 2020
First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks. First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology.
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The Pharma Data
SEPTEMBER 6, 2020
This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. months, not reached). months, not reached).
XTalks
DECEMBER 19, 2023
As we approach the end of 2023, a retrospective look at the statistics from 2022 reveals the top 20 drugs dominating retail sales. In this article, we will explore the factors contributing to the success of the top 20 drugs in 2023 by retail sales from the prior year. 1) Comirnaty (COVID-19 Vaccine, mRNA) Sales in 2022: $37.81
XTalks
NOVEMBER 15, 2023
The FDA says chikungunya is an emerging global health threat as at least 5 million cases of chikungunya virus infection have been reported in the last 15 years. Valneva recently reported that it has been experiencing an increase in sales of its other vaccines due to the “recovery of the travel industry.”
The Pharma Data
AUGUST 27, 2020
The test is FDA-approved to report short variants in 311 genes including rearrangements and copy number losses in BRCA1 and BRCA2 genes. The results are delivered in an integrated report that identifies alterations matched to FDA-approved therapies.
The Pharma Data
MAY 18, 2021
5 percent of the tumour area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The advisory committee provides the FDA with independent opinions and recommendations from outside medical experts though the recommendations are not binding.
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