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NeuroSense Gets FDA Agreement for ALS Study

[ Price : $8.95]

Based on FDA feedback, NeuroSense Therapeutics says it will begin a Phase 3 study of PrimeC (ciprofloxacin and celecoxib) for trea...

Carvykti Shows Favorable Minimal Residual Disease Data

[ Price : $8.95]

Johnson & Johnson reports data from its Phase 3 CARTITUDE-4 study that show Carvykti significantly increased minimal residual dise...

OCI Case Nets 2 on HIV, Covid Drug Convictions

[ Price : $8.95]

Two men are convicted of securities fraud in a case involving misrepresented submissions to FDA for a drug purportedly intended to...

CGMP Violations at Chinas Guangzhou Four Es

[ Price : $8.95]

FDA warns Chinas Guangzhou Four Es Scientific Co. about CGMP violations in its production of finished drugs.

Getinge/Maquet Recalls VasoView HemoPro 2

[ Price : $8.95]

Getinge/Maquet issues a Class 1 recall (device correction) to inform users about important safety information for its VasoView Hem...

FDA Stem Cell Regulation Court Ruling Analyzed

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Four Ropes & Gray attorneys analyze a 9th Circuit Appeals Court decision backing FDA regulation of stem cell products and raise th...

FDA Denies Metacel Ozobax Petition

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FDA denies a Metacel petition asking the agency to require flavoring tests for generic forms of the companys Ozobax.

ICH Model-Informed Drug Development Guide Out

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FDA publishes a draft International Council for Harmonization M15 guidance on model-informed drug development principles.

Sepsis Risk Assessment Test Gets Breakthrough Status

[ Price : $8.95]

FDA grants MeMed a breakthrough device designation for its MeMed Severity test, intended for use in determining risk assessments i...

Favorable Pirtobrutinib Data in Leukemia/Lymphoma: Lilly

[ Price : $8.95]

Confirmatory data evaluating Eli Lillys pirtobrutinib in adult patients with chronic lymphocytic leukemia or small lymphocytic lym...