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Methinks AI Stroke Detection Software Cleared

[ Price : $8.95]

FDA clears a Methinks AI 510(k) for its Methinks CTA Stroke, an artificial intelligencebased software tool that detects suspected ...

Drug Development Context Inventory Out

[ Price : $8.95]

FDA releases a table of drug development contexts that could be used to help reduce animal testing.

New Life Medical Selling Unapproved HCT/Ps

[ Price : $8.95]

FDA warns Lutz, FL-based New Life Medical Services that it is illegally marketing unapproved human cells, tissues, and cellular an...

Create Enhanced Drugs Pathway: Petition

[ Price : $8.95]

Age Reversal Unity petitions FDA to create a new regulatory pathway to cover so-called enhanced drugs to fight aging as a disease.

Complement Therapeutics Gene Therapy Cleared for Trial

[ Price : $8.95]

Complement Therapeutics gains IND clearance to begin human testing of its lead gene therapy, CTx001, in patients with geographic a...

Vivaces Hippo Pathway Drug VT3989 Gets Fast Track

[ Price : $8.95]

FDA grants Vivace Therapeutics a fast track designation for its lead cancer drug VT3989, a first-in-class TEAD autopalmitoylation ...

3 CGMP Violations at Naturich Cosmetique

[ Price : $8.95]

FDA warns Garland, TX-based Naturich Cosmetique about CGMP violations in its production of finished drugs.

Trividia Recalls 1 Lot of Glucose Meters

[ Price : $8.95]

FDA says Trividia Health has recalled 601 blood glucose meters that may have defective LCD displays.

FDA Rejects Xspray Pharmas Leukemia Drug NDA

[ Price : $8.95]

FDA issues Xspray Pharma a complete response letter on its NDA for Dasynoc (dasatinib) and its use for treating chronic myeloid le...

Lilly Partial Win Over FDAs Biologic Classification

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A federal judge gives Eli Lilly a partial win in a lawsuit challenging FDAs refusal to classify retatrutide the companys investig...