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Participant’s Diagnosis Halts Gene Therapy Clinical Trial
The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.
Participant’s Diagnosis Halts Gene Therapy Clinical Trial
Participant’s Diagnosis Halts Gene Therapy Clinical Trial

The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.

The FDA pauses the research program on a lentivirus-based treatment for a rare neurological condition after a patient developed a bone marrow disorder that could presage leukemia.

FDA, genetics & genomics

gene therapy approval used manipulated data
Some Data Backing Novartis Gene-Therapy Approval Manipulated: FDA
Nicoletta Lanese | Aug 7, 2019 | 2 min read
The agency is now evaluating the implications of the corrupted data behind Zolgensma and whether to “take action” against the pharmaceutical company.
MyHeritage Launches Health-Related Genetic Test, Ignites Debate
Catherine Offord | Jul 9, 2019 | 8 min read
Its screen for selected variants of some disease-linked genes gives customers an incomplete picture of their risk—do they know?
FDA Lifts Import Restrictions on Genetically Engineered Salmon
Catherine Offord | Mar 11, 2019 | 2 min read
The fast-growing fish can now be raised and sold in the US, although it’s likely to be some time before the product hits the market.
USDA Approves Edible Cotton
Jef Akst | Oct 29, 2018 | 2 min read
While farmers have the green light to grow the genetically engineered plant, FDA approval is still needed before the seeds are sold as food.
The NIH Loosens Grip on Gene Therapy Trials
Kerry Grens | Aug 16, 2018 | 2 min read
The agency proposes ceding its scrutiny of these studies to the FDA.
The Superpowers of Genetically Modified Pigs
Kerry Grens | Aug 1, 2018 | 4 min read
Scientists have engineered swine that pollute less, fend off disease, and produce more meat, but you won’t find them outside experimental farms . . . yet.
Opinion: No, FDA Didn’t Really Approve 23andMe’s BRCA Test
Cecile Janssens | Mar 19, 2018 | 3 min read
Rather, the breast cancer mutation screen was classified as a type of medical device with obligations for the company to reduce risks to customers.
First Direct-to-Consumer BRCA Test Authorized by FDA
Kerry Grens | Mar 6, 2018 | 2 min read
The agency gave personal genomics company 23andMe the green light to screen samples for breast cancer–related genetic mutations.
Foundation Medicine’s Cancer Gene Test Gains FDA and CMS Approval
Diana Kwon | Dec 1, 2017 | 1 min read
The Centers for Medicare and Medicaid Services propose covering the test with Medicare. 
The Rising Research Profile of 23andMe
Catherine Offord | Nov 30, 2017 | 7 min read
An exploration of the genetics of earlobe attachment is just the latest collaborative research project to come out of the personal genetic testing company.
FDA OKs Marketing of DTC Genetic Health-Risk Tests
Diana Kwon | Apr 7, 2017 | 2 min read
23andMe customers can now receive information about genetic risk for diseases including Parkinson’s and celiac.
Drug Produced in GM Chicken Approved
Jef Akst | Dec 10, 2015 | 1 min read
The US Food and Drug Administration greenlights a rare-disease drug that is produced in the eggs of genetically modified chickens.
Following FDA OK, 23andMe to Expand Health Prediction
Kerry Grens | Oct 21, 2015 | 2 min read
The personal genomics firm is ramping up its suite of disease-related genetic tests.
FDA OKs 23andMe Test
Kerry Grens | Feb 20, 2015 | 1 min read
The US Food and Drug Administration will allow the personal genomics company to resume a disease-risk analysis.
FDA Gets Into the Lab Test Game
Bob Grant | Aug 4, 2014 | 2 min read
So-called laboratory-developed tests will eventually face regulations similar to those that currently govern diagnostic tests or kits that are sold to hospitals.
Week in Review: February 3–7
Tracy Vence | Feb 6, 2014 | 3 min read
Federal stem cell regulations vary; Salmonella exploit host immune system; microglia help maintain synaptic connections; prosthesis re-creates feeling of touch
Speaking of Science
The Scientist | Jan 1, 2014 | 2 min read
January 2014's selection of notable quotes
23andMe Steps Back
Abby Olena, PhD | Dec 6, 2013 | 2 min read
The company announces that it will stop offering health interpretations of personal genetic data.
FDA Approves NGS Tests
Tracy Vence | Nov 21, 2013 | 1 min read
The agency has cleared marketing of four next-generation sequencing devices from Illumina.
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