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FDA Says Contaminated Cough Meds not in U.S.

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FDA says it is monitoring reports of contaminated childrens cough and cold medicines manufactured in India but confirmed that the ...

Drug Development Context Inventory Out

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

Public Rating of FDA, Others Dropping

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A Gallup Poll shows that Americans ratings of FDA and many other federal agencies have dropped in the last year to at or near thei...

Fast Track Awarded to Adcendos Sarcoma Drug

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FDA grants Adcendo a fast track designation for ADCE-D01, an investigational antibody-drug conjugate being developed for treating ...

72% of Breakthrough Drugs Win Approval: Jefferies Analysis

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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.