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FDA Study: CBD Linked to Elevated Liver Enzymes

[ Price : $8.95]

An FDA clinical trial finds that daily use of cannabidiol at levels typically used by consumers can cause elevated liver enzymes i...

Priority Review for Gamida sBLA for Omidubicel

[ Price : $8.95]

FDA accepts for priority review a Gamida Cell supplemental BLA for omidubicel and its use in severe aplastic anemia.

Vanda Urges Makary to Intercede in Generic Dispute

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Vanda Pharmaceuticals urges FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generi...

AdvaMed Urges FDA/CMS Alignment on Breakthrough Devices

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AdvaMed and other device stakeholders urge the Centers for Medicare & Medicaid Services to overhaul how it covers new device techn...

Boston Scientific Recalls Defective Stent System

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Boston Scientific recalls (Class 1) its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that created an in...

FDA 483 Shows GMP Troubles at Plant Making Eylea

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A new Form FDA-483 cites significant GMP issues at the plant that makes Regenerons Eylea HD (aflibercept), delaying review of two ...

FDA Clears Signos OTC Glucose Monitor

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FDA clears a Signos 510(k) for what the company says is the first over-the-counter glucose monitoring system designed specifically...

FDA Moves to Daily Drug Adverse Event Data

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FDA is now publishing drug safety data on a daily basis, a shift the agency says will give the public faster access to information...

Stealth Gets Expedited Review on NDA Resubmission

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FDA accepts for review a Stealth BioTherapeutics NDA resubmission for elamipretide for treating Barth syndrome, with the agency ag...

Nicox Plans NDA for Glaucoma Drug

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Nicox plans an NDA early next year after new data from its DENALI Phase 3 study of glaucoma therapy NCX 470 showed promising resul...