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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...

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Medical Devices

Olympus Recalls Insufflation Units

Olympus recalls its high-flow insufflation units (model UHI-4) that are used in laparoscopic surgeries after receiving reports about patients sufferin...

Medical Devices

Breakthrough Device Changes Needed: Research

Researchers from several U.S. academic medical centers suggest steps FDA and CMS could take to tighten CMS supplemental reimbursement for new medical ...

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Federal Register

Draft Guide on Remote Interactive Evaluations

Federal Register notice: FDA releases a draft guidance entitled Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facili...