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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 ...

FDA Accepts Sandoz Neulasta Biosimilar Application

[ Price : $8.95]

FDA accepts Sandoz regulatory submission for a biosimilar of Amgens Neulasta.

FDA Approves Medtronic MyCareLink Monitor

[ Price : $8.95]

FDA approves Medtronics MyCareLink remote pacemaker monitoring system.

FDA Issues Staff Social Media Policy

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FDA issues a policy on staff use of social media on behalf of the agency and its mission.

FDA Sends Info on Tropical Disease Vouchers to OMB

[ Price : $8.95]

Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget pertaining to a g...

Comments Sought on Safety Reporting, Electronic Submissions

[ Price : $8.95]

Federal Register Notice: FDA seeks comments on a proposed collection of information on the FDA Electronic Submission Gateway and t...