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Medical Devices

SQ Innovation Gets Edema At-Home Treatment OKd

FDA approves SQ Innovations drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) in adult patients wit...

FDA General

GOP Senators Call on FDA to Restrict Generic Mifepristone

Fifty-one Republican senators urge FDA to restrict access to abortion pills following the agencys recent approval of a new generic version of mifepris...

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Human Drugs

Glioblastoma Multiforme Drug Gets Orphan Status

FDA awards Precision NeuroMed an orphan drug designation for IL13-PE38QQR (cintredekin besudotox), an investigational therapy targeting glioblastoma m...

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Human Drugs

FDA Says Contaminated Cough Meds not in U.S.

FDA says it is monitoring reports of contaminated childrens cough and cold medicines manufactured in India but confirmed that the affected products di...

Human Drugs

Drug Development Context Inventory Out

FDA releases a table of drug development contexts that could be used to help reduce animal testing.

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FDA General

Public Rating of FDA, Others Dropping

A Gallup Poll shows that Americans ratings of FDA and many other federal agencies have dropped in the last year to at or near their lowest point.

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Human Drugs

Fast Track Awarded to Adcendos Sarcoma Drug

FDA grants Adcendo a fast track designation for ADCE-D01, an investigational antibody-drug conjugate being developed for treating soft tissue sarcoma.

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Human Drugs

72% of Breakthrough Drugs Win Approval: Jefferies Analysis

A new analysis from investment firm Jefferies finds that nearly three-quarters of drug candidates that received an FDA breakthrough therapy designatio...

Medical Devices

Methinks AI Stroke Detection Software Cleared

FDA clears a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligencebased software tool that detects suspected large vessel occlusi...

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Human Drugs

8 Items on Aurobindo FDA-483

FDA releases the form FDA-483 with eight observations from an inspection at the Aurobindo Pharma drug manufacturing facility in Bachupally, Hyderabad,...