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FDA Approves Rare Infant Disease Gene Therapy

Neurons

The Food and Drug Administration today approved a treatment for spinal muscular atrophy in young children that replaces a faulty gene in motor neurons with a healthy one. . . . → Read More: FDA Approves Rare Infant Disease Gene Therapy

Trial Shows Surgical Pain Managed Without Opioids

Head in hands

Results from a clinical trial show patients recovered from their hernia surgeries with non-opioid pain medications, and stayed off opioids for 15 days. . . . → Read More: Trial Shows Surgical Pain Managed Without Opioids

FDA Issues Final Biosimilar Guidance

Pills and dollar bill

The Food and Drug Administration issued its final guidance on regulating the interchangeability of so-called biosimilars with original biologic drugs. . . . → Read More: FDA Issues Final Biosimilar Guidance

Trial Testing Heart Device Outcomes by Gender

Heart check

A clinical trial is underway tracking patients with implanted heart devices for 3 years to find any differences in health outcomes between men and women. . . . → Read More: Trial Testing Heart Device Outcomes by Gender

Kidney Diagnostics Receive FDA Breakthrough Tag

Data and person graphic

An algorithm-driven diagnostic test for chronic kidney disease is receiving a breakthrough device designation from the Food and Drug Administration. . . . → Read More: Kidney Diagnostics Receive FDA Breakthrough Tag

FDA Approves Transplant Lung Preservation System

Human lungs illustration

The Food and Drug Administration approved a medical device that restores and maintains lungs for transplants that may not otherwise be acceptable. . . . → Read More: FDA Approves Transplant Lung Preservation System

Gel Boosts T-Cells for Cancer Treatments

T-cells illustration

A biomedical engineering team devised techniques using a gel to produce more engineered T-cells, which in lab mice stopped the growth of tumors. . . . → Read More: Gel Boosts T-Cells for Cancer Treatments

Lung Model Developed to Test E-Cigarettes, Hookah

Juul e-cigarette

A three-dimensional model of a human lung is being developed to test health effects of new trends in smoking, such as electronic cigarettes and hookahs. . . . → Read More: Lung Model Developed to Test E-Cigarettes, Hookah

FDA Expands Evidence Project to Replace Trials

Data and person graphic

The Food and Drug Administration is expanding a demonstration project with a Boston teaching hospital that tests the value of real world evidence to replace some clinical trials. . . . → Read More: FDA Expands Evidence Project to Replace Trials

FDA Approves Single Dual-Drug Pill for HIV

HIV released from cell

The Food and Drug Administration approved a daily pill with 2 drugs to lower viral loads in people with HIV, but who have not yet taken other HIV drugs. . . . → Read More: FDA Approves Single Dual-Drug Pill for HIV