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Revised Safety Alert on Alcons CyPass Micro-Stent

[ Price : $8.95]

FDA issues a revised safety alert on Alcons CyPass Micro-Stent due to its risk of eye damage.

Masimo RD SET for Pulse Oximetry Cleared

[ Price : $8.95]

FDA clears a Masimo 510(k) for the RD SET sensors with Masimo Measure-through Motion and Low Perfusion SET pulse oximetry that is ...

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

[ Price : $8.95]

FDA publishes a draft guidance on legal requirements for drug supply chain verification systems.

FDA Approves Saxenda Label Update on CV Risk

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Tanezumab Study Meets Efficacy Endpoints

[ Price : $8.95]

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

[ Price : $8.95]

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