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FDA Launches Pilot to Speed Up Meeting Minutes

[ Price : $8.95]

FDA launches a new meeting minutes pilot program aimed at reducing delays and confusion that often follow formal meetings between ...

Siemens Healthineers Warning on MRI Machines

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

Firm to Pay $38.5 Million Over Failed Knee Implants

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

Individuals Accused of Extorting Indias Hetero Drugs

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

Multiple Violations in DermaRite Inspection

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FDA warns North Bergen, NJ-based DermaRite Industries about CGMP, unapproved new drug, and misbranded drug violations in its produ...

Epcoritamab Combo for Relapsed Follicular Lymphoma OKd

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

Verdure Sciences Did Not Submit Trial IND: FDA

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

Redemplo OKd for Cutting High Triglycerides in Rare Disorder

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FDA approves an Arrowhead Pharmaceuticals NDA for Redemplo (plozasiran) for reducing dangerously high triglyceride levels in adult...

Roches Giredestrant Promising Data in Early Breast Cancer

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Roche says its investigational selective estrogen receptor degrader giredestrant significantly improved invasive disease-free surv...

Significant CGMP Violations at World Perfumes

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