Given M2A Has Higher Diagnostic Yield Compared With Other Tests – CEO
This article was originally published in The Gray Sheet
Executive Summary
Given Imaging is looking to tap into a $15 mil. U.S. irritable bowel syndrome (IBS) diagnostic market with an upcoming generation of the M2A wireless endoscopy imaging capsule with motility features
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Financings In Brief
Alliance Medical: Initial public offering will await FDA clearance of five additional 510(k) submissions for reprocessed disposable medical devices, the firm said. The Phoenix company, which has already received clearances for 15 out of 20 510(k)s submitted to the agency, withdrew its August 2001 IPO registration statement March 15. "We feel that conditions for raising money from the public market will be better after FDA has acted on our remaining 510(k) submissions," Alliance explained in a release...
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.