Accelerating Early Access to Immunotherapies for Advanced Urothelial Carcinoma

por Ning, Yang‐Min, Maher, V. Ellen, Beaver, Julia A., Goldberg, Kirsten B., Blumenthal, Gideon M., Pazdur, Richard
Publicado 2017

Publisher Correction: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency

por Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Publicado 2022

Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency

por Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Publicado 2022

Correction to: Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency

por Sellers, Jenn W., Mihaescu, Camelia M., Ayalew, Kassa, Kronstein, Phillip D., Yu, Bei, Ning, Yang-Min, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Publicado 2022

FDA Approval Summary: Atezolizumab for the Treatment of Patients with Progressive Advanced Urothelial Carcinoma after Platinum‐Containing Chemotherapy

por Ning, Yang‐Min, Suzman, Daniel, Maher, V. Ellen, Zhang, Lijun, Tang, Shenghui, Ricks, Tiffany, Palmby, Todd, Fu, Wentao, Liu, Qi, Goldberg, Kirsten B., Kim, Geoffrey, Pazdur, Richard
Publicado 2017

Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency

por Ayalew, Kassa, Ning, Yang-Min, Foringer, Michelle J., Leibenhaut, Susan, Sellers, Jenn W., Yu, Bei, Kronstein, Phillip D., Higgerson, Agata, Mihaescu, Camelia, Rodriguez, Miguel, Williams, LaKisha, Khin, Ni A.
Publicado 2022

FDA Approval Summary: Atezolizumab or Pembrolizumab for the Treatment of Patients with Advanced Urothelial Carcinoma Ineligible for Cisplatin‐Containing Chemotherapy

por Suzman, Daniel L., Agrawal, Sundeep, Ning, Yang‐min, Maher, V. Ellen, Fernandes, Laura L., Karuri, Stella, Tang, Shenghui, Sridhara, Rajeshwari, Schroeder, Jason, Goldberg, Kirsten B., Ibrahim, Amna, McKee, Amy E., Pazdur, Richard, Beaver, Julia A.
Publicado 2018

Cabozantinib plus Nivolumab Phase I Expansion Study in Patients with Metastatic Urothelial Carcinoma Refractory to Immune Checkpoint Inhibitor Therapy

por Girardi, Daniel M., Niglio, Scot A., Mortazavi, Amir, Nadal, Rosa, Lara, Primo, Pal, Sumanta K., Saraiya, Biren, Cordes, Lisa, Ley, Lisa, Ortiz, Olena Sierra, Cadena, Jacqueline, Diaz, Carlos, Bagheri, Hadi, Redd, Bernadette, Steinberg, Seth M., Costello, Rene, Chan, Keith S., Lee, Min-Jung, Lee, Sunmin, Yu, Yunkai, Gurram, Sandeep, Chalfin, Heather J., Valera, Vladimir, Figg, William D., Merino, Maria, Toubaji, Antoun, Streicher, Howard, Wright, John J., Sharon, Elad, Parnes, Howard L., Ning, Yang-Min, Bottaro, Donald P., Cao, Liang, Trepel, Jane B., Apolo, Andrea B.
Publicado 2022