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llllllllll paxalisib (GDC-0084) / KaziaUS FDA Grants Rare Pediatric Disease Designation (RPDD) to Paxalisib for DIPG (PRNewswire) - Aug 7, 2020 - "Kazia Therapeutics Limited...is pleased to announce that the United States Food and Drug Administration (FDA) has awarded Rare Pediatric Disease Designation (RPDD) to Kazia's paxalisib (formerly GDC-0084) for the treatment of Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly-aggressive childhood brain cancer...In October 2018, St Jude Children's Research Hospital in Memphis, TN commenced a phase I clinical trial of paxalisib in DIPG (NCT03696355)....The study has completed recruitment, and initial efficacy data is anticipated during the second half of calendar 2020."llllllllll aducanumab (BIIB037) / Eisai, BiogenFDA Accepts Biogen’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review (GlobeNewswire) - Aug 7, 2020 - "Biogen...and Eisai, Co., Ltd....today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for aducanumab, an investigational treatment for Alzheimer’s disease. The application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date on March 7, 2021, and the FDA has stated that, if possible, it plans to act early on this application under an expedited review."
