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Nature City Settles FTC Claims for $537,500

The Federal Trade Commission says a Florida federal court has approved a settlement with Nature City over the companys false and unsubstantiated healt...

Human Drugs

Dont Use Cannabis When Pregnant, Breastfeeding: FDA

FDA cautions against use of cannabis products by women who are pregnant or breastfeeding.

Medical Devices

J&J, Ethicon Settle Mesh Marketing Suits for $116.9 Million

Pennsylvania attorney general Josh Shapiro says Johnson & Johnson and its Ethicon subsidiary have settled allegations of deceptive marketing of transv...

Human Drugs

Foamix Pharma NDA for Rosacea Foam Filed

FDA accepts for review a Foamix Pharmaceuticals NDA for FMX103 (minocycline topical foam 1.5%) topical foam for treating moderate-to-severe papulopust...

Human Drugs

Expanded Indication for Genentech Flu Drug

FDA approves a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and o...

Human Drugs

Viatrexx Recalls Sterile Injectable Products

Viatrexx Bio recalls all products in 10 mL sterile injectable vials because they were manufactured in a manner that cannot guarantee their sterility.

Human Drugs

Panel Backs Shionogo Urinary Tract Infection Drug

An FDA advisory committee votes 14 to 2 to recommend approval of a Shionogi NDA for cefiderocol injection for its proposed indication to treat complic...

Human Drugs

Ipsen Asks Somatuline ANDA Restrictions

Ipsen asks FDA to require in vivo bioequivalence for any ANDA citing its Somatuline Depot as the reference-listed drug.

Medical Devices

Fidmi Medical Enteral Feeder Cleared

FDA clears a Fidmi Medical 510(k) for its low-profile enteral feeding device.

Human Drugs

Greenleaf Adds Good Clinical Practice Services

Greenleaf Health adds good clinical practice services to its range of FDA regulatory consulting.