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Animal Drug Regs Amended on Review Actions

[ Price : $8.95]

Federal Register notice: FDA amends the animal drug regulations to reflect application-related actions for new animal drug applica...

New CDER Web Page Housing EUA Docs/Requirements

[ Price : $8.95]

CDER creates a new Web page to house scientific review documents supporting emergency use authorizations for drug and biological t...

Becerra HHS Confirmation May Free Up FDA Nomination

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The U.S. Senate confirms California attorney general Xavier Becerra as HHS secretary, a move that could expedite the nomination of...

Life Spine Prolift Wedge Clearance

[ Price : $8.95]

FDA clears a Life Spine 510(k) for the Prolift Wedge Expandable Spacer System.

FDA Says ACIST Recall of Kodama Catheter is Class 1

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FDA says the ACIST recall of 490 units of its Kodama intravascular ultrasound catheter is Class 1.

Tremfya Arthritis Benefits Last Through 2 Years: Janssen

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Janssen says treatment benefits from its Tremfya in psoriatic arthritis have been shown to last two years.

Students Suggest Ways to Improve FDA Draft Antisense Oligonucleotide Guidance

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Three students in a Duke University Science Regulation Lab course offer suggestions for FDA to improve a draft guidance on adminis...

GSK Opens Phase 3 Asthma Study Using Anti-IL-5 Treatment

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GlaxoSmithKline launches a Phase 3 trial of its GSK294 biologic to treat eosinophilic asthma.

FDA Grants De Novo for Covid Diagnostic

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FDA grants BioFire Diagnostics a De Novo marketing authorization for the BioFire Respiratory Panel 2.1, a diagnostic test for the ...

FDA Touts Alternative Inspection Oversight Results

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FDA acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Judy McMeekin say the agency has succeede...