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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...

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Human Drugs

Probiotics Can Hurt Hospitalized Preterm Infants: FDA

FDA outlines the risks associated with off-label use of probiotics in hospitalized preterm infants to treat necrotizing enterocolitis.

Biologics

Positive Data on Pfizer/BioNTech Combo Vaccine

Pfizer and BioNTech announce positive topline results from their Phase 1/2 study that is evaluating the safety, tolerability and immunogenicity of mRN...