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JD Supra: FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU
JD Supra· 1 day agoOn April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2 ...
FDA Finalizes Rule to Assert Authority Over Laboratory Developed Tests | JD Supra
JD Supra· 6 days agoThe Food and Drug Administration (FDA) published its long-awaited Final Rule that will regulate laboratory developed tests (LDTs) as in vitro diagnostic (IVD) medical devices ...
Moderna Tumbles After The FDA Throws A Curveball On Its Second Product
Investor's Business Daily· 1 day agoThe news pushes back the potential approval of the vaccine for respiratory syncytial virus by...
New research reports on financial entanglements between FDA chiefs and the drug industry
Medical Xpress· 3 days agoAn investigation published by The BMJ today raises concerns about financial entanglements between US...
No evidence Tyson Foods received FDA approval to add insects to human food | Fact check
USA TODAY via Yahoo News· 2 days agoThe claim: FDA approved use of insects in human food by Tyson Foods An April 24 Facebook post (direct link, archive link) shows the Tyson Foods logo next to an image of mealworms ...
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria | CNN
CNN.com· 2 days agoThe US Food and Drug Administration is considering a requirement for blood banks to use a new test...
Moderna Stock Seesaws After The FDA Throws It A Curveball
Investor's Business Daily· 2 days agoThe FDA was due to make a decision by May 12. Moderna emphasized the FDA has not said it found any...
FDA recalls popular diabetes care app after glitches result in injuries to 224 patients
Scripps News via AOL· 2 days agoA glitch in a version of Tandem Diabetes Care's Apple iOS app that is used with certain insulin...
FDA Chief on H5N1: 'We Have to Be Ready'
MedPage Today· 4 days agoFDA Commissioner Robert Califf, MD, described his agency's role in helping to prevent a wider outbreak of H5N1 avian influenza during a hearing of the...
FDA issues recall statement after insulin pump-related IOS app causes injuries
NBC Universal via AOL· 3 days agoThe FDA has issued a statement following the Class I recall for an IOS app used in conjunction with...
