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FDA Orphan Drug Designation for Allogene Cancer Drug

[ Price : $8.95]

FDA grants Allogenes ALLO-715 orphan drug status for treating multiple myeloma.

Jazz Pharma Hypersomnia Drug Approved

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FDA approves a Jazz Pharmaceuticals NDA for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for treating ...

Clinical Hold on Bluebird Bio Gene Therapy

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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

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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

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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

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

SterRx Recalls 3 Sodium Bicarbonate Lots

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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

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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

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