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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...

Paige AI Lymph Node Gets Breakthrough

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

FDA Trims, Updates Biosimilars Labeling

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

Probiotics Can Hurt Hospitalized Preterm Infants: FDA

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

Positive Data on Pfizer/BioNTech Combo Vaccine

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

Olympus Recalls Insufflation Units

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