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FDA says it has amended its electronic submission Technical Rejection Criteria for Study Data to require study data standards in c...[ Price : $8.95]
FDA sends Dynavax Technologies a Complete Response Letter on its BLA for Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)...[ Price : $8.95]
FDA clears a CapsoVision 510(k) for the CapsoCam Plus small bowel capsule endoscope system.[ Price : $8.95]
Federal Register Notice: FDA issues a debarment order against Edward Manookian (also known as Ed Manning) based on a finding that ...[ Price : $8.95]
FDA grants Novartis a priority review for an NDA for midostaurin, indicated for treating acute myeloid leukemia in newly-diagnosed...[ Price : $8.95]
Pfizer says that an FDA-ordered safety study of Pfizers arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiova...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on the Reporting of Biologica...[ Price : $8.95]
FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-...