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Expanded Indication for Genentech Flu Drug

[ Price : $8.95]

FDA approves a Genentech supplemental NDA for Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 1...

Viatrexx Recalls Sterile Injectable Products

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

Panel Backs Shionogo Urinary Tract Infection Drug

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

Ipsen Asks Somatuline ANDA Restrictions

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

Fidmi Medical Enteral Feeder Cleared

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

Greenleaf Adds Good Clinical Practice Services

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

Firm Gets Breakthrough Status for Prostate Cancer Test

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FDA grants Cleveland Diagnostics a breakthrough device designation for the IsoPSA Assay, a prostate cancer diagnostic test.

Nonvoting Rep Sought for Tobacco Science Panel

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Federal Register notice: FDA requests nominations for a nonvoting representative to serve on the Tobacco Products Scientific Advis...

FDA Sets Record in Generic Drug Approvals

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FDA acting commissioner Ned Sharpless says FDA has set a record for generic drug approvals in FY 2019.

FDA Tobacco Ad Rule Violates 1st Amendment: WLF

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Washington Legal Foundation cites a drug advertising court case in arguing that a proposed FDA tobacco labeling rule violates the ...