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FDA Issues Draft Precision Medicine Trial Guidance

The U.S. Food and Drug Administration issued draft regulatory guidance on clinical trials for new treatments that target genetic mutations rather than disease states. . . . → Read More: FDA Issues Draft Precision Medicine Trial Guidance

FDA Fast-Tracks Heart Failure Gene Therapy

A biotechnology company developing transfers of healthy genes to treat chronic diseases is receiving an accelerated review of its heart failure therapy from the U.S. Food and Drug Administration. . . . → Read More: FDA Fast-Tracks Heart Failure Gene Therapy

Current Drug Helps Cut Opioid Use After Surgery

Results from a clinical trial show patients given a current non-opioid pain medication with different types of surgery were less likely to use opioids for up to a year later. . . . → Read More: Current Drug Helps Cut Opioid Use After Surgery

MIT Building Statewide Health Innovation System

A unit of Massachusetts Institute of Technology is establishing what it calls an innovation ecosystem that pulls together different players in health care to better serve the needs of patients. . . . → Read More: MIT Building Statewide Health Innovation System

CAR T-Cells Shown Effective in Long-Term Studies

Results from two clinical studies of engineered immune system cells show patients continue to respond their treatments after 6 months or more. . . . → Read More: CAR T-Cells Shown Effective in Long-Term Studies

PTSD Drug Trial Begins, Gets Fast-Track Status

An experimental drug that aims to keep nerve cells flexible is beginning an early-stage clinical trial as a treatment for post-traumatic stress disorder, or PTSD. . . . → Read More: PTSD Drug Trial Begins, Gets Fast-Track Status

Emergency Sealant Gel Developed for Eye Injuries

A medical engineering team created a gel material that safely closes injured eye tissue until surgical treatments can be given. . . . → Read More: Emergency Sealant Gel Developed for Eye Injuries

Tobacco Plants Studied as Drug Bio-Factories

A university in Australia is joining a European research project to create new types of tobacco plants for producing pharmaceuticals. . . . → Read More: Tobacco Plants Studied as Drug Bio-Factories

Cell Programming Company Raises $49.5M in Early Funds

A start-up enterprise creating add-on treatments that program the effects of cell and gene therapies is raising $49.5 million in its first venture funding round. . . . → Read More: Cell Programming Company Raises $49.5M in Early Funds

Large-Scale Process Devised for Lab-Made Liver Tissue

Researchers in Japan and the U.S. created techniques for producing liver tissue in large quantities in the lab for transplant or drug testing. . . . → Read More: Large-Scale Process Devised for Lab-Made Liver Tissue