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Human Drugs

Researchers Develop MRI-Friendly Protein Micelle

New York University researchers say they have developed nanoscale protein micelles that can both deliver drug therapy and be tracked by MRI.

Medical Devices

NEST Real-World Evidence Activities Updated

CDRH director Jeffrey Shuren updates work of the National Evaluation System for health Technology in assessing how real-world evidence can be used to ...

Medical Devices

Siemens Mobilett X-ray System Cleared

FDA clears a Siemens Healthineers 510(k) for the Mobilett Elara Max mobile X-ray system, which features improved information technology security as we...

Human Drugs

FDA OKs Losartan with NMBA Below 9.82 PPM

FDA says it is allowing temporary distribution of losartan with NMBA levels up to 9.82 ppm to ease a supply shortage.

Human Drugs

Partial Hold on Abbvie/Roche Myeloma Trial

FDA places a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatmen...

Human Drugs

Nutra Pharma Warned on Illegal Marketing

FDA sends a Warning Letter to Nutra Pharma for illegally marketing unapproved products labeled as homeopathic with claims for treating addiction and c...

Human Drugs

Mylan Recalls 2 Lots of Levoleucovorin Injection

Mylan recalls two lots of levoleucovorin injection, 250 mg/25 mL due to the presence of particulate matter that has been identified as copper salts.

Biologics

Genentech sBLA OKd for Tecentriq in Lung Cancer

FDA approves a Genentech sBLA for Tecentriq (atezolizumab) for combination use with carboplatin and etoposide for first-line treatment of adults with ...

Medical Devices

QS Issues at TEI Biosciences

FDA warns TEI Biosciences about Quality System violations in its manufacturing of collagen-based medical devices.

Human Drugs

CGMP Violations at 2 United Exchange Facilities

FDA warns United Exchange about CGMP violations at two facilities producing finished pharmaceuticals.