On November 15, the U.S. Food and Drug Administration (FDA) released its final rule on Requirements for Additional Traceability Records for Certain Foods (Food Traceability Rule). The rule defines ...

This September, the U.S. Food and Drug Administration (FDA) released its proposed update to the nutrient content claim “healthy.” Used in food package labeling, the term is intended to help busy ...

“With the strength of our Phase 3 data as the foundation of our submission, we look forward to continuing to work closely with the FDA through the review of our BLA [biologics license application] on ...

Jacqueline Corrigan-Curay, acting director of the FDA’s Center for Drug Evaluation and Research, said in a news release. “This action and the agency’s designations to expedite the drug’s ...

Bruce Lahn, Chief Scientist at VectorBuilder, commented, "Congratulations to Chengdu Ucello on the FDA IND approval of ... producer cell line for lentiviral vector manufacturing.

Under the EU QP-certified GMP system, VectorBuilder has developed a consistent lentiviral vector manufacturing process which can help bring down the cost per single dose of CAR-T cell therapy to ...

Many existing and proposed regulations are now under fire and face rollbacks. But the new administration's pick to lead Health and Human Services, which oversees FDA, wants a say in regulating ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

US FDA Approves Novo Nordisk's Ozempic to Cut Risk of Diabetic Kidney Disease Progression (Reuters) -The U.S. FDA has approved Novo Nordisk's Ozempic for reducing the risk of kidney failure and ...

An audit released by the Inspector General of the U.S. Department of Health and Human Services, the parent organization of the Food and Drug Administration (FDA), is not a pleasant read. Let us turn ...