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Clinical Hold on Bluebird Bio Gene Therapy

[ Price : $8.95]

FDA places a clinical hold on Bluebird Bios Lenti-D (elivaldogene autotemcel) after the company reported a suspected unexpected se...

Patient Engagement Panel on Device Recalls

[ Price : $8.95]

Federal Register notice: FDA announces a 10/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendat...

FDA Wants More Study of FibroGen Roxadustat

[ Price : $8.95]

An FDA complete response letter asks FibroGen to conduct additional roxadustat clinical studies before resubmitting its NDA.

FDA Says Vivera Selling Adulterated, Misbranded Covid Tests

[ Price : $8.95]

FDA warns Vivera Pharmaceuticals it is marketing unapproved, adulterated, and misbranded Covid-19 tests.

SterRx Recalls 3 Sodium Bicarbonate Lots

[ Price : $8.95]

SterRx recalls three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamina...

Could Be Weeks Before FDA Chief is Named: CNN

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CNN reports it has been told by two administration officials that it could be weeks until a permanent FDA commissioner is named.

Ables Mach Screw Clip Cleared by FDA

[ Price : $8.95]

FDA clears an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device.

Single-use ENT Scope Cleared for Use

[ Price : $8.95]

FDA clears a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat Scope.

Lantern Orphan Status for Pancreatic Cancer Drug

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FDA grants Lantern Pharma an orphan drug designation for LP-184 and its use in treating pancreatic cancer.

FDA Seeks Consumer Reps for Advisory Panels

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...