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Boston Scientific Recalls Defective Stent System

[ Price : $8.95]

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

[ Price : $8.95]

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

[ Price : $8.95]

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

Stealth Gets Expedited Review on NDA Resubmission

[ Price : $8.95]

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

[ Price : $8.95]

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

Gaps Seen in Dementia AI Device Transparency

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Researchers call for greater transparency of artificial intelligence/machine learning training and validation datasets in devices ...

FDA OKs Ionis Hereditary Angioedema Drug

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FDA approves an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for heredit...

Rinvoq Meets Endpoints in Alopecia Trial

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AbbVie reports that its JAK inhibitor Rinvoq (upadacitinib) met primary and secondary endpoints in a pivotal Phase 3 study testing...

21% of FDA Staff Gone: Analysis

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An in-depth ProPublica report details the effects of massive staffing cuts at FDA and other HHS agencies that experts say threaten...

14 States Join Mifepristone Petition to FDA

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14 states join a petition submitted by four other states calling on FDA to eliminate the mifepristone REMS requirements in their s...