U.S. LLC / Technical Operations Onyx Pharmaceuticals Inc. / M.D. / Onyx Pharmaceuticals Inc. / Research & Development / Sanofi / Clinical Development Onyx Pharmaceuticals Inc. / Science & Biometrics Onyx Pharmaceuticals Inc. / Drugs Advisory Committee Sponsor Presentation Introduction Onyx Pharmaceuticals Inc. / D. / /
Event
FDA Phase / /
Facility
M.D. University of Colorado FDA Presentation NDA / M.D. University of Rochester Semuloparin Efficacy / FDA White Oak Campus / White Oak Conference Center / /
IndustryTerm
Cancer Prevention / /
MedicalCondition
multiple myeloma / colorectal cancer / metastatic solid tumors / bladder cancer / symptomatic deep vein thrombosis / cancer / disease / lung cancer / deep vein thrombosis / venous thromboembolism / nonfatal pulmonary embolism / /
MedicalTreatment
chemotherapy / /
Organization
office of Biostatistics / office of Translational Science / office of New Drugs / Food and Drug Administration / Harvard / University of Colorado / office of Hematology / Emory University / Treatment Fund / Hematology and Oncology Products office of New Drugs / FDA / Oncologic Drugs Advisory Committee / University of Rochester Semuloparin Efficacy / Center for Drug Evaluation and Research / Statistical Reviewer Division / Advisory Committee / /
Person
Kyung Yul Lee / Antoinette J. Wozniak / Efficacy Barbara Klencke / M.D. Sr. / Kevin Kelly / Sonia Nagda / Aman U. Buzdar / Howard Fingert / Albert Deisseroth / James Omel / Silver Spring / Safety Natalie Sacks / Kallappa Koti / Caleb Briggs / Mikkael Sekeres / Roy Baynes / Benjamin (Doug) Rickert Diane / Tito Fojo / Veena Agarwal Robin / Stephen Barrager Walter / Michael Tuohy Benjamin (Doug) / Kenneth C. Anderson / Wyndham Wilson (Chairperson) / Oncologic Drugs / Walter M. Capone / Frank Balis / Libby Mullin / Jeanne Herndon / Diane Moran / Patrick Loehrer / Thomas Herndon / Michael Menefee / Jane Zones / Ted W. Love / James D. Neaton / Ann Farrell / Louis F. Diehl / Julie M. Vose / Wyndham Wilson / Richard Pazdur / Aman Buzdar / Statistical Reviewer / Safety Francesca Lawson / Brent Logan / Paul Westrick Libby / Kyung Y. Lee / Tal Zaks / Deborah K. Armstrong / Ralph Freedman / Robin Tuohy / Karen Arscott / Kathy Robie-Suh / Richard Gural / /
Position
VP / Chair Committee / Officer / Director and Chief / Medical Officer Division of Hematology Products / Federal Officer / Director / Chairperson / Major / Representative / speaker for the Open Public Hearing session / EVP / Professor and Vice Chair / /
FOOD AND DRUG ADMINISTRATION (FDA)