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FDA creates transparency principles for AI in medical devices
MedTech Dive via Yahoo Finance· 6 hours agoThe agency worked with regulators in the U.K. and Canada to determine how key information about...
FDA official: The risk of secondary cancer from CAR-T therapy is less than feared
Medical Xpress· 2 hours agoThe risk of secondary cancer after CAR-T therapy, pioneered at Penn, is less than regulators feared...
What Happens When You Stop Taking Ozempic?
PureWow via Yahoo News· 2 hours agoUnless you’ve been living under a rock, you’re likely familiar with Ozempic, the miracle weight loss drug that has made headlines, shown up in your news...
FDA approves generic Emflaza oral suspension for Duchenne muscular dystrophy
Medical Xpress· 1 hour agoThe U.S. Food and Drug Administration has approved the first generic version of Emflaza...
Cucumber recall update as FDA sets highest risk level
Newsweek· 1 day agoA range of recalled whole cucumbers have been designated a Class I risk level by the U.S. Food and...
Novavax seeks FDA approval for updated Covid-19 vaccine
Pharmaceutical Technology via Yahoo Finance· 7 hours agoNovavax has submitted an application to the US Food and Drug Administration (FDA) seeking approval...
Xeltis sets crosshairs on US pivotal trial for aXess after IDE green light
Medical Device Network via Yahoo Finance· 51 minutes agoThe US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) to...
FDA halts trial of BioNTech-MediLink ADC over 'significant risk of illness'
FierceBiotech· 2 hours agoThe FDA has slammed the brakes on MediLink Therapeutics’ trial of a BioNTech-partnered antibody-drug...
AstraZeneca/Fibrogen’s Roxadustat FDA Review Further Delayed Following Unanticipated Advisory...
Clinical Trials Arena via Yahoo Finance· 10 hours agoFDA Delays Decision on AstraZeneca/Fibrogen’s Roxadustat for CKD Anemia On March 1, AstraZeneca and...
Amgen's (AMGN) Blincyto Gets FDA Nod for Consolidation Treatment
Zacks via Yahoo Finance· 2 hours agoAmgen's (AMGN) Blincyto is now approved for the treatment of adult and pediatric patients one month...