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Centessa Scraps Lixivaptan in Kidney Disease

[ Price : $8.95]

Centessa Pharmaceuticals discontinues its development of lixivaptan for autosomal dominant polycystic kidney disease after due to ...

Illumina Cybersecurity Vulnerability: FDA

[ Price : $8.95]

FDA says a cybersecurity vulnerability in some Illumina next-generation sequencing instruments could affect patient results.

Aeglea Bio Hit With BLA Refusal-to-File Letter

[ Price : $8.95]

FDA sends Aeglea BioTherapeutics a refusal-to-file letter for its BLA for pegzilarginase, indicated for treating arginase 1 defici...

FDA Will Review Myfembree sNDA with New Safety Info

[ Price : $8.95]

FDA sets 1/29/23 as the PDUFA action date for a Pfizer/Myovant sNDA to update the labeling of Myfembree.

Atrium Medical Recalls iCast Stent System

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Atrium Medical recalls its iCast Covered Stent System after receiving increased customer complaints about the balloon or catheter ...

Doctors Sue FDA Over Ivermectin for Covid

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Three doctors sue FDA over the agencys efforts to prevent the use of ivermectin to treat Covid-19.

Bill to Streamline Generic Drug Approvals

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Sens. Hassan and Paul introduce a bill to require FDA to more clearly identify differences between a generic and its reference-lis...

Novartis Gets Expanded OK for Kymriah

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FDA grants Novartis accelerated approval for Kymriah (tisagenlecleucel) for treating adult patients with relapsed or refractory fo...

Coronary Artery Disease Risk Indicators in Class 2

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Federal Register notice: FDA classifies coronary artery disease risk indicators using acoustic heart signals into Class 2 (special...

Coordinate on Drug Patent Oversight: Senators

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Sens. Cassidy and Hassan call on FDA and the Patent and Trademark Office to better coordinate and communicate on drug patent appli...