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FDA Warns Cord Blood-Stem Cell Company

E. coli bacteria

Food and Drug Administration recently warned GeneTech Inc. that its unauthorized stem cell regenerative medicine products, may be causing serious blood infections. . . . → Read More: FDA Warns Cord Blood-Stem Cell Company

Validation Scheme Proposed for Medical Algorithms

Biocircuits illustration

A law school professor urges developers, users, and regulators of machine learning in medicine to validate the algorithms that represent their underlying decision-making processes. . . . → Read More: Validation Scheme Proposed for Medical Algorithms

FDA Clears Mobile App for Opioid Use Disorder

Man with smartphone

The Food and Drug Administration authorized a mobile app, when prescribed by clinicians for patients with opioid use disorder in outpatient treatment programs. . . . → Read More: FDA Clears Mobile App for Opioid Use Disorder

Report – 289 Cell and Gene Therapies in Development

Human T-cell

A report by a pharmaceutical industry organization says nearly 300 new therapies that transfer live cells or genes as treatments for disease are in clinical trials or being reviewed by Food and Drug Administration. . . . → Read More: Report – 289 Cell and Gene Therapies in Development

FDA Identifies Database to Evaluate Precision Diagnostics

DNA puzzle

The Food and Drug Administration identified a public database of genomics and diseases as a resource to assess new diagnostics tests using genetic data for precision medicine. . . . → Read More: FDA Identifies Database to Evaluate Precision Diagnostics

Trials OK’d for Inherited Eye Disease Therapy with Crispr

Crispr-Cas9 illustration

The company developing a treatment for a rare inherited eye disease using the genome editing technique Crispr received authorization from the Food and Drug Administration to begin clinical trials. . . . → Read More: Trials OK’d for Inherited Eye Disease Therapy with Crispr

FDA Approves Biomarker-Targeting Cancer Drug

DNA methylation illustration

The Food and Drug Administration yesterday approved a treatment for solid tumor cancers that focuses on specific cancer-causing genetic conditions rather than location of the cancer in the body. . . . → Read More: FDA Approves Biomarker-Targeting Cancer Drug

Trial Shows Treatment Prevents Peanut Allergy Reactions

Peanutes in shells

Final results from a clinical trial show a preventive treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year. . . . → Read More: Trial Shows Treatment Prevents Peanut Allergy Reactions

Survey Shows Sharp Rise in Teen E-Cigarette Use

Juul e-cigarette

New data from a continuing survey of smoking among school-age children shows large increases in electronic cigarette use in high school and middle school children in just the past year. . . . → Read More: Survey Shows Sharp Rise in Teen E-Cigarette Use

FDA Updating Expanded Access to Investigational Drugs, Devices

Scott Gottlieb

The Food and Drug Administration says it’s streamlining policies for making drugs and medical devices in clinical trials or under review available for people in the U.S. with life-threatening conditions. . . . → Read More: FDA Updating Expanded Access to Investigational Drugs, Devices