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Medical Devices

Siemens Healthineers Warning on MRI Machines

Siemens Healthineers issues an urgent safety correction (Class 1 recall) for dozens of its 3 Tesla MRI models after identifying a potentially catastro...

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Medical Devices

Firm to Pay $38.5 Million Over Failed Knee Implants

Aesculap Implant Systems agrees to pay $38.5 million to resolve federal allegations under the False Claims Act that it knowingly sold defective knee r...

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Human Drugs

Individuals Accused of Extorting Indias Hetero Drugs

A business TV station in India says two persons have been arrested for impersonating FDA officials and attempting to extort Hetero Drugs.

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Human Drugs

Epcoritamab Combo for Relapsed Follicular Lymphoma OKd

FDA approves Genmabs Epkinly (epcoritamab-bysp) for combination with lenalidomide and rituximab in adults with relapsed or refractory follicular lymph...

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Human Drugs

Verdure Sciences Did Not Submit Trial IND: FDA

FDA warns Noblesville, IN-based Verdure Sciences about failing to submit an IND for a clinical study of its investigational drug Maplifa.

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Human Drugs

Redemplo OKd for Cutting High Triglycerides in Rare Disorder

FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adults with familial chyl...

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Human Drugs

Roches Giredestrant Promising Data in Early Breast Cancer

Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free survival in certain peop...

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Human Drugs

Significant CGMP Violations at World Perfumes

FDA warns Opa-Locka, FL-based World Perfumes about CGMP violations in its production of finished drugs as a contract manufacturer.

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Human Drugs

FDA, Patent Office at Odds on Biosimilars: CBS News Report

CBS News says the federal patent office is taking steps to slow challenges to innovator biologic drug patents by biosimilar drug makers, while FDA is ...

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Human Drugs

FDA Needs More Data on China Drug Production: Report

A congressional commission on U.S.-China relations calls on Congress to authorize FDA to collect data from drug companies on where their drug componen...