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FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 4 days agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 5 days agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
It’s Official: Tara Flour Is an Unapproved Food Additive, According to the FDA
Eating Well via Yahoo News· 6 days agoTara flour made headlines in 2022 after hundreds got sick from Daily Harvest crumbles. Now the FDA...
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
BioPharma Dive via Yahoo Finance· 3 days agoBut the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening...
US FDA staff flags risk of low blood sugar for Novo Nordisk’s weekly insulin
KFGO· 5 days ago(Reuters) - The U.S. Food and Drug Administration's (FDA) staff on Wednesday pointed to "notable...
House Members Question FDA Officials on Lab-Developed Tests, Missed Deadlines
MedPage Today· 6 days agoWith all the news about drug shortages, there's another type of possible shortage that the public...
U.S. FDA advisers back approval for Guardant's blood-based cancer test (May 23) By Reuters
Investing.com· 4 days agoThe panel voted seven-to-two in favor of benefits outweighing risks when using the test called...
FDA panel recommends approval of a blood test for colon cancer
NBC NEWS· 4 days agoIf approved, Shield could become the second blood-based test for colon cancer diagnosis in the...
FDA upgrades safety alert for Hologic's breast cancer marking implant, after 71 reported injuries
FierceBiotech· 3 days agoThe FDA is upgrading its safety warnings related to complications from Hologic’s implantable marker...
US FDA staff says Guardant's test may fail to detect some pre-cancerous tumors
Reuters via Yahoo News· 6 days agoThe reviewers, however, said the test may increase compliance with screening for colorectal cancer...