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FDA Approves Celltrions Eylea Biosimilar

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FDA approves Celltrions Eydenzelt (aflibercept-boav), a biosimilar referencing Regeneron and Bayers blockbuster Eylea for treating...
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FDA Updates Carvykti Labeling With Boxed Warning

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FDA approves new labeling for Janssen Biotechs Carvykti (ciltacabtagene autoleucel, including a Boxed Warning highlighting the ris...
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SQ Innovation Gets Edema At-Home Treatment OKd

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FDA approves SQ Innovations drug-device combination Lasix ONYU (furosemide injection) for treating edema (due to fluid overload) i...
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GOP Senators Call on FDA to Restrict Generic Mifepristone

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Fifty-one Republican senators urge FDA to restrict access to abortion pills following the agencys recent approval of a new generic...
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Glioblastoma Multiforme Drug Gets Orphan Status

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FDA awards Precision NeuroMed an orphan drug designation for IL13-PE38QQR (cintredekin besudotox), an investigational therapy targ...
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FDA Says Contaminated Cough Meds not in U.S.

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FDA says it is monitoring reports of contaminated childrens cough and cold medicines manufactured in India but confirmed that the ...
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Drug Development Context Inventory Out

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FDA releases a table of drug development contexts that could be used to help reduce animal testing.
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Public Rating of FDA, Others Dropping

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A Gallup Poll shows that Americans ratings of FDA and many other federal agencies have dropped in the last year to at or near thei...
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Fast Track Awarded to Adcendos Sarcoma Drug

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