Federal Register Notice: FDA issues a debarment order against Edward Manookian (also known as Ed Manning) based on a finding that he was convicted of ...
FDA grants Novartis a priority review for an NDA for midostaurin, indicated for treating acute myeloid leukemia in newly-diagnosed adults with an FMS-...
Pfizer says that an FDA-ordered safety study of Pfizers arthritis drug Celebrex (celecoxib) demonstrated similar rates of cardiovascular risk in patie...
FDA sends Dynavax Technologies a Complete Response Letter on its BLA for Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)] for immunization o...
Former Pfizer Global Research and Development president and Forbes contributor John LaMattina believes FDA will lower its approval standards under pre...
Federal Register Notice: FDA withdraws two proposed rules published over five years ago because they are outdated.
Thermo Fisher Scientific files the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequencing-based assay for ...
FDA says it has amended its electronic submission Technical Rejection Criteria for Study Data to require study data standards in conformance to requir...