FDA, Exact Sciences and Cologuard
Exclusive-Thermo Fisher's plant making infant RSV drug breached FDA rules, documents show
By Patrick Wingrove (Reuters) -One of the largest contract drug manufacturing plants in the U.S. owned by Thermo Fisher ...
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Atsena lands another FDA incentive for gene therapy to fight blindness
Atsena Therapeutics, a Durham company developing gene therapies to treat genetic causes of blindness, has received another ...
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FDA approves the first new schizophrenia drug in over 30 years
FARGO — A new FDA approved drug, to help people with schizophrenia, will soon be accessible for medical officials to ...
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EPA, FDA, and USDA Release Tool to Help Companies Developing Microbial Biotechnology Products Navigate Regulatory Landscape
On October 2, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Food and Drug Administration (FDA), and U.S.
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FDA's drug cen­ter launch­es new co­or­di­nat­ing body for mod­el­ing and sim­u­la­tion
The FDA's Center for Drug Evaluation and Research on Wednesday officially launched a new center of excellence to better ...
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FDA Clears Cologuard Plus for Colorectal Cancer Screening
The approval was based on data from the BLUE-C trial, which assessed the sensitivity and specificity of the Cologuard Plus test vs FIT in asymptomatic adults scheduled for screening colonoscopy.
Summit Therapeutics Stock Jumps as Lung Cancer Drug Placed on FDA Fast Track
Key Takeaways Summit Therapeutics stock jumped Friday morning, a day after the company said its developmental lung cancer ...
FDA recalls chocolate cone treat sold in Kansas
A Colorado-based candy shop issued a recall after discovering one of its products caused an allergic reaction. The Food and ...