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SN Bioscience Receives FDA Fast Track Designation for Small Cell Lung Cancer
The Pilot News· 5 hours agoSN Bioscience Co. Ltd. (CEO Park Young-hwan) announced on May 7 that the FDA has granted Fast Track...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
CNN via Yahoo News· 10 hours agoThe US Food and Drug Administration is considering a requirement for blood banks to use a new test...
FDA recalls popular diabetes care app after glitches result in injuries to 224 patients
Scripps News via AOL· 8 hours agoA glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin...
FDA urges providers to ‘transition away’ from Getinge cardiovascular life support pumps
FierceBiotech· 15 hours agoFollowing 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life...
WestGene's mRNA Therapeutic Cancer Vaccine Receives FDA Approval
The Sun Chronicle· 5 hours agoWestGene, a biotech company dedicated to mRNA technology, announces a historic milestone with the ...
US FDA advises healthcare facilities to switch from Getinge's heart devices
Reuters· 17 hours ago, opens new tab heart devices in patients as they faced safety and quality concerns despite a string...
FDA Issues Final Guidance to Clarify "Remanufacturing" of Devices that Need Maintenance or Repair
WFRV 5 Green Bay· 19 hours ago"Today's action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices," said Jeff Shuren, M.D., J.D., director ...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 4 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
FDA issues recall statement after insulin pump-related IOS app causes injuries
NBC Universal via AOL· 17 hours agoThe FDA has issued a statement following the Class I recall for an IOS app used in conjunction with...
The FDA misses its own deadline to propose a ban on formaldehyde from hair products
NPR· 15 hours agoThe federal agency proposed the ban in October 2023 and scheduled its implementation for April 2024....