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Clinical Hold on AML Cell Therapy

[ Price : $8.95]

FDA places a clinical hold on a 2seventy bio Phase 1 study (PLAT-08) of SC-DARIC33 in acute myeloid leukemia after a patient death...

Guide on Off-the-Shelf Software in Devices

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FDA posts a final guidance entitled Off-The-Shelf Software Use in Medical Devices.

Astellas sNDA Filed for Pediatric Cresemba

[ Price : $8.95]

FDA accepts for review an Astellas Pharma supplemental NDA for Cresemba (isavuconazonium sulfate), an azole antifungal drug for tr...

Ceribells ClarityPro For Detecting Seizures

[ Price : $8.95]

FDA clears a Ceribell 510(k) for its new software ClarityPro for diagnosing electrographic status epilepticus in adults.

FDA Warning on 15 Universal Meditech Tests

[ Price : $8.95]

FDA warns the public not to use 15 tests manufactured by Universal Meditech after the company notified the agency that it has stop...

FDA On Parametric Release for Sterile Drugs

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FDA addresses whether parametric release is an appropriate control strategy for sterile drug products that are not terminally ster...

Genprex Gets Orphan Status for Reqorsa

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FDA grants Genprex an orphan drug designation for Reqorsa immunogene therapy (quratusugene ozeplasmid) and its use for treating sm...

Data on Under-Represented Patients Guide

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Federal Register notice: FDA makes available a draft guidance entitled Postmarketing Approaches to Obtain Data on Under-Represente...

Guide on Biosimilar Supplement Classifications

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Federal Register notice: FDA makes available a draft guidance entitled Classification Categories for Certain Supplements Under BsU...

Anjeso Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Baudax Bios Anjeso (meloxicam) solution, 30 mg/mL, was not withdrawn from sale due to...