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FDA Reclassifies Salivary Stimulator

[ Price : $8.95]

Federal Register Final order: FDA reclassifies the salivary stimulator system into Class 2 and renaming it the electrical salivary...

FDA Classifies UV Radiation Chamber into Class 2

[ Price : $8.95]

Federal Register Final order: FDA classifies the ultraviolet radiation chamber disinfection device into Class 2.

FDA Exempts Electric Chair Devices

[ Price : $8.95]

Federal Register Final order: FDA grants a petition seeking exemption from premarket notification requirements for electric positi...

Major Review Concerns on Kyndrisas Safety/Efficacy

[ Price : $8.95]

FDA reviewers express major safety/efficacy concerns that may hamper approval of a Biomarin NDA for Kyndrisa (drisapersen) for tre...

FTC Wants Effexor Court Ruling Reversed

[ Price : $8.95]

The Federal Trade Commission asks an appeals court to reverse a lower court ruling that a Wyeth and Teva Effexor reverse-payment a...

St. Judes Proclaim Spinal Cord Stimulator for Pain Approved

[ Price : $8.95]

FDA approves a St. Jude Medical PMA for the Proclaim Elite Spinal Cord Stimulation System, which the company describes as the firs...

FDA Approves Adapts Narcan Nasal Spray

[ Price : $8.95]

FDA approves an Adapt Pharma NDA for Narcan (naloxone hydrochloride) nasal spray, the first FDA-approved nasal spray indicated to ...

Joint FDA Panel Votes Down Bladder Cancer Drug

[ Price : $8.95]

An FDA joint advisory committee meeting votes 6 to 18 to not recommend approval for a Telesta Therapeutics BLA for Mycobacterium p...

Glaukos Files IND for Travoprost Intraocular Implant

[ Price : $8.95]

Glaukos Corp. files an IND seeking authorization to study its Travoprost Intraocular Implant with the iDose delivery system to red...

44 Freshmen Members in Congress Urge Device Tax Repeal

[ Price : $8.95]

U.S. congresswoman Elise Stefanik (R-NY) leads a bipartisan group of 44 freshmen members of Congress in sending a letter to House ...