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Review Extended on Denalis Hunter Syndrome Drug

[ Price : $8.95]

FDA extends by three months its review of a Denali Therapeutics BLA for tividenofusp alfa, a potential treatment for Hunter syndro...

Medtronics Endurant Gains Expanded Indication

[ Price : $8.95]

FDA approves an expanded indication for Medtronics Endurant II/IIs Stent Graft System, allowing its use in abdominal aortic aneury...

FDA Awards Breakthrough Status to Lymphoma Drug

[ Price : $8.95]

FDA grants BeOne Medicines a breakthrough therapy designation for sonrotoclax and its use in treating adults with relapsed or refr...

Troubled Novo Nordisk Facility Gets OAI Status

[ Price : $8.95]

FDA assigns an Official Action Indicated classification to a recent inspection of a Novo Nordisk manufacturing facility in Bloomin...

FDA Approves Celltrions Eylea Biosimilar

[ Price : $8.95]

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

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...

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...

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...

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...