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Human Drugs

Deciphera Pharma Planning NDA for Vimseltinib

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

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Human Drugs

Lillys Ulcerative Colitis Therapy Approved

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

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Human Drugs

TX Man Gets 5 Years Over Unapproved Drugs

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

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Human Drugs

Vabysmo OKd for Retinal Vein Occlusion Edema

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

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Human Drugs

Sickle Cell Therapy Safety Assessment Questioned

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

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Human Drugs

Bill to Reduce Dependence on China Drugs

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

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Human Drugs

FDA OKs Loqtorzi for Nasopharyngeal Carcinoma

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

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Medical Devices

Class 1 Recall of Infusion Pump Syringes

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

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Medical Devices

Paige AI Lymph Node Gets Breakthrough

FDA grants Paige a breakthrough device designation for its Paige Lymph Node, an artificial intelligence application used to detect breast cancer metas...

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Human Drugs

FDA Trims, Updates Biosimilars Labeling

FDA Office of Therapeutic Biologics and Biosimilars director Sarah Yim trims biosimilars labeling while soliciting public comments on the usefulness o...