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Medical Devices

FDA Clears Viz.ai Algorithm

FDA clears a Viz.ai algorithm to give the ratio between right and left ventricle diameters in a patients heart for use in pulmonary embolism treatment...

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Human Drugs

Former Pharmatech CEO Gets 37 Months in Jail

A Florida federal judge sentenced the former CEO of Pharmatech to 37 months in federal prison after he pled guilty to several charges of lying to and ...

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Human Drugs

Ascendis NDA for Hypoparathyroidism Therapy

Ascendis Pharma files an NDA for TransCon PTH, an investigational prodrug designed to restore parathyroid hormone (PTH [1-34]) to physiological levels...

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Biologics

FDA Authorizes Moderna, Pfizer-BioNTech Boosters

FDA authorizes Modernas and Pfizer-BioNTechs updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two months following prima...

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Biologics

FDA Loses California Stem Cell Treatment Case

A California federal judge rejects FDA regulation of a stem cell clinic, saying it is engaged in the practice of medicine.

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Medical Devices

Novo Nordisk Pays $6.3 Million Over False Claims

Novo Nordisk agrees to pay $6.3 million to resolve allegations that it violated the False Claims Act by selling its NovoFine needles to U.S. governmen...

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Human Drugs

FDA OKs Genzymes Xenpozyme for ASMD

FDA approves Genzymes Xenpozyme to treat acid sphingomyelinase deficiency in children and adults.

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Human Drugs

Changes Sought in Drug Shortage Draft Guidance

Two major drug trade associations ask for changes in an FDA draft guidance on risk management plans to mitigate drug shortages.

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Medical Devices

Baxter New Novum IQ Syringe Pump Cleared

FDA clears a Baxter International 510(k) clearance of its new Novum IQ syringe infusion pump with Dose IQ Safety Software.

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Human Drugs

Amneal Files NDA for Parkinsons Drug

Amneal Pharmaceuticals files an NDA for IPX203, a novel formulation of carbidopa/levodopa extended-release capsules for treating Parkinsons disease.