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Human Drugs

FDA Expands Rinvoq Label for Crohns, Ulcerative Colitis

AbbVie gains an updated label for Rinvoq (upadacitinib), expanding its use in treating adults with moderately to severely active ulcerative colitis an...

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Biologics

FDA Approves Celltrions Eylea Biosimilar

FDA approves Celltrions Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayers blockbuster Eylea for treating several major retin...

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Human Drugs

FDA Updates Carvykti Labeling With Boxed Warning

FDA approves new labeling for Janssen Biotechs Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the risk of immune effector...

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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.