Regulatory News In Brief
This article was originally published in The Gray Sheet
Executive Summary
Direct-to-consumer genetics tests panel
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Illness Risk Fuels FDA Ban On Powdered Surgical Gloves
An FDA determination of substantial risk of illness and injury from use of absorbable powdered surgical gloves has sparked a proposed product ban by the agency.
FDA Announces Possible Link Between Breast Implants And Cancer
In response to data suggesting that breast implants may be associated with a rare form of cancer, FDA plans to work with manufacturers on revised product labeling, the agency announced Jan. 26.
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.