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Ractigen Gets Orphan Status for Duchennes

[ Price : $8.95]

FDA grants Ractigen Therapeutics an orphan drug designation for RAG-18 and its use in treating Duchenne Muscular Dystrophy.

Amgens Blincyto Gets Expanded Approval

[ Price : $8.95]

FDA approves Amgens Blincyto (blinatumomab) for treating adult and pediatric patients with CD19-positive Philadelphia chromosome-n...

Half of AI Devices Lack Clinical Validation Data: Research

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A group of researchers find that about half of the over 500 AI devices allowed to enter the market since 2016 lack reported clinic...

iRhythm Hit With 2nd FDA-483 in a Month

[ Price : $8.95]

FDA turns up the pressure on iRhythm Technologies based on a second Form FDA-483 issued last month at the companys Cypress, CA man...

Rhythm Files for Imcivree Expanded Use

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FDA accepts for priority review a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide), for treating obesity due t...

Excela Diltiazem Not Withdrawn for Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Exela Pharma Sciences diltiazem HCl in dextrose, 125mg/125mL and 250mg/250mL were not...

FDA Withdraws 2 MQSA Alternative Standards

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Federal Register notice: FDA announces the withdrawal of two Mammography Quality Standards Act (MQSA) alternative standards due to...

BeiGene Gets Fast Track on Leukemia Therapy

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FDA grants BeiGene a fast track designation for BGB-16673 and its use in adult patients with relapsed or refractory chronic lympho...

Omnipod 5 Expanded Clearance for Type 2 Diabetes

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FDA clears an Insulet 510(k) for the Omnipod 5 Automated Insulin Delivery System (Omnipod 5) for use by those with Type 2 diabetes...

Public Citizen Calls for Shuren Probe by OIG

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Public Citizens Health Research Group calls on HHS Office of Inspector General to investigate allegations that retiring CDRH direc...