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Priority Voucher Awarded to Leadiant Bioscience

[ Price : $8.95]

Federal Register notice: FDA awards a priority review voucher to Leadiant Bioscience after determining that rare disease drug Revc...

Economic Advisors Praise FDA on Drug Costs

[ Price : $8.95]

The Council on Economic Advisors says FDA efforts to control drug prices are providing savings to consumers.

Drug Supply Chain Verification System Guidance

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FDA publishes a draft guidance on legal requirements for drug supply chain verification systems.

FDA Approves Saxenda Label Update on CV Risk

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FDA approves an updated label for Novo Nordisks Saxenda to add cardiovascular risk data for the drugs active ingredient from the L...

Servicing/Remanufacturing White Paper, Workshop

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FDA issues a white paper outlining issues to be discussed at a December workshop on the distinctions between medical device servic...

Rocky Mountain Orthodontics Gains Orthocaps Clearance

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FDA clears a Rocky Mountain Orthodontics 510(k) for Orthocaps, a transparent and removable appliance for correcting tooth malposit...

Tanezumab Study Meets Efficacy Endpoints

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Pfizer and Lilly say a Phase 3 trial of their novel osteoarthritis monoclonal antibody met all three co-primary efficacy endpoints...

Genentech Flu Drug Approved by FDA

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FDA approves Genentechs Xofluza (baloxavir marboxil) for treating acute, uncomplicated influenza in people 12 years of age and old...

Joint Panel to Mull Increasing Naloxone in Communities

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Federal Register notice: FDA announces a 12/17 joint advisory committee meeting to discuss strategies to increase the availability...

2007 FDA Law Brought Better Trial Reporting: Study

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A new study concludes that the FDA Amendments Act (FDAAA) of 2007 has led to more clinical trials being registered and results bei...