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FDA Roundup: May 24, 2024
KOIN News 6 Portland· 2 hours agoOn Thursday, the FDA announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using ...
With Duchenne decision ahead, FDA’s Marks pushes for speedy gene therapy approvals
BioPharma Dive via Yahoo Finance· 9 hours agoBut the head of the FDA’s CBER office didn’t tip where the agency stands on potentially broadening...
Blood test to detect colon cancer could move a step closer to FDA approval in the US
CNN via Yahoo News· 23 hours agoGuardant Health’s Shield tests could be the first approved blood screening test for colorectal...
FDA approves CorTec’s implant system for stroke rehabilitation study
Medical Device Network via Yahoo Finance· 12 hours agoThe US Food and Drug Administration (FDA) has granted approval for an investigational device...
FDA seeks AI tech to predict, detect Parkinson’s symptoms
MedTech Dive via Yahoo Finance· 3 days agoBy testing artificial intelligence and machine learning models, the agency hopes to come up with...
FDA's Draft Guidance On Safety Testing Of Human Allogeneic Cells For Use In Cell-Based Therapies
BioresearchOnline· 14 hours agoIn April 2024, the U.S. FDA released the draft guidance titled Safety Testing of Human Allogeneic...
FDA panel backs Guardant’s blood test for colon cancer
MedTech Dive via Yahoo Finance· 10 hours agoPanelists stressed the need for labeling and education for physicians and patients to make clear...
Medline, Chinese manufacturer launch recalls for plastic syringes
MedTech Dive via Yahoo Finance· 9 hours agoMedline told customers in an April safety notice to stop using plastic syringes in convenience kits...
FDA Approves Biosimilars for Macular Degeneration Treatment
Healthline via AOL· 2 days agoThe FDA approved two interchangeable biosimilars to treat macular degeneration. The biosimilars work...
Indica Labs’ HALO AP Dx platform receives FDA 510(k) clearance
Medical Device Network via Yahoo Finance· 1 day agoIndica Labs has received 510(k) clearance from the US Food and Drug Administration (FDA) for its...
