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Novartis Seeks Accelerated OK for IgAN Drug

[ Price : $8.95]

Novartis says it will seek FDA accelerated approval for atrasentan and its use in treating patients with IgA nephropathy.

Impulse Dynamics Heart Device OKd for MRI

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FDA approves Impulse Dynamics Optimizer Smart Mini system for whole-body MRI-conditional use.

Deciphera Pharma Planning NDA for Vimseltinib

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Deciphera Pharmaceuticals says it will file an NDA in the second quarter of 2024 for vimseltinib for treating patients with tenosy...

Lillys Ulcerative Colitis Therapy Approved

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FDA approves an Eli Lilly BLA for Omvoh (mirikizumab-mrkz) infusion, described as the first interleukin-23p19 (IL-23p19) antagonis...

TX Man Gets 5 Years Over Unapproved Drugs

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A federal court in Texas sentences Evan Asher Field to five years in prison for selling unapproved drugs through the mail.

Vabysmo OKd for Retinal Vein Occlusion Edema

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FDA approves Genentechs Vabysmo (faricimab-svoa) for treating macular edema following retinal vein occlusion.

Sickle Cell Therapy Safety Assessment Questioned

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FDA reviewers plan to ask an advisory committee 10/31 whether Vertex Pharmaceuticals and CRISPR Therapeutics need to conduct addit...

Bill to Reduce Dependence on China Drugs

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Senator Marco Rubio introduces a bill entitled Further Strengthening Americas Supply Chains and National Security Act to reduce Am...

FDA OKs Loqtorzi for Nasopharyngeal Carcinoma

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FDA approves a Coherus BioSciences and Junshi Biosciences BLA for Loqtorzi (toripalimab-tpzi) in combination with cisplatin and ge...

Class 1 Recall of Infusion Pump Syringes

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Cardinal Health recalls certain lots of its Monoject luer-lock tip syringes (1, 6, 12, 20, 35 and 60 mL) after the company documen...