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72% of Breakthrough Drugs Win Approval: Jefferies Analysis

[ Price : $8.95]

A new analysis from investment firm Jefferies finds that nearly three-quarters of drug candidates that received an FDA breakthroug...

Methinks AI Stroke Detection Software Cleared

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

Prasad Puts Together CBER Leadership Team

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CBER director Vinay Prasad orchestrates leadership changes at the Center, appointing several new acting deputy directors and reass...

D.C. Federal Court Backs Carve-Out Label

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The D.C. federal court says FDA correctly approved labeling for MSNs generic form of Novartis Entresto.

New Life Medical Selling Unapproved HCT/Ps

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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

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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

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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

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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

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

Trividia Recalls 1 Lot of Glucose Meters

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