referring to empr
Malaria Vaccine Receives Fast Track Status from FDA
Malaria Vaccine Receives Fast Track Status from FDA
Malaria Vaccine Receives Fast Track Status from FDAThe vaccine is currently under investigation in clinical trials in the U.S., Europe and AfricaThe Food and Drug Administration (FDA) has granted Fast Track designation to Sanaria PfSPZ Vaccine, a preventative vaccine for malaria.Sanaria PfSPZ Vaccine is currently under investigation in clinical trials in the U.S., Europe and Africa for patients as young as 6 months old to adults.These trials are intended to establish and optimize an immunization regimen against all strains of Plasmodium falciparum malaria, which will be used for the vaccine's upcoming Phase 3 trials.
besides mesothelioma
FDA Fast Track Puts Mesothelioma Cancer Vaccine in the Spotlight
FDA Fast Track Puts Mesothelioma Cancer Vaccine in the Spotlight
Get Your FREE Resources Sent Overnight Discover the latest treatmentsDiscover the latest treatments Learn to improve your prognosisLearn to improve your prognosis Get financial aid for medical expenses Full Name Street Address City / State / Zip Phone E-Mail GET YOUR FREE RESOURCES PLEASE WAIT...FDA Fast Track Puts Mesothelioma Cancer Vaccine in the SpotlightThis week, the maker of a mesothelioma vaccine got good news – they were approved for fast track designation.When the U.S. Food and Drug Administration (FDA) grants a fast track designation to a drug, it's a big deal – it means that the agency believes that it has the potential of filling an unmet need in the treatment of a serious condition.The designation is not given lightly: a drug manufacturer has to request the designation at some point during the drug development process, and then the FDA reviews the request to determine whether it has merit.
not to mention prnewswire
Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation
Sanaria® PfSPZ Vaccine Against Malaria Receives FDA Fast Track Designation
Sanaria® PfSPZ Vaccine is in clinical trials in subjects ranging in age from 6-month old infants to adults in the U.S., Europe and Africa.These trials are intended to finalize an immunization regimen to be taken forward into pivotal phase 3 clinical trials that will, if successful, provide the necessary data for licensing the vaccine.Stephen Hoffman, CEO of Sanaria, said, "U.S. FDA Fast Track designation for our malaria vaccine is a strong indicator that we've gotten beyond the proof of science and are moving toward licensure.
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