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FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum.
Singh, Sonia; Bradford, Diana; Li, Xiaoxue; Mishra-Kalyani, Pallavi S; Shen, Yuan-Li; Wang, Lingshan; Zhao, Hong; Xiong, Ye; Liu, Jiang; Charlab, Rosane; Kraft, Jeffrey; Khasar, Sachia; Miller, Claudia P; Rivera, Donna R; Kluetz, Paul G; Pazdur, Richard; Beaver, Julia A; Singh, Harpreet; Donoghue, Martha.
Affiliation
  • Singh S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Bradford D; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Li X; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Mishra-Kalyani PS; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Shen YL; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Wang L; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Zhao H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Xiong Y; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Liu J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Charlab R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kraft J; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Khasar S; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Miller CP; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Rivera DR; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Kluetz PG; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Pazdur R; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Beaver JA; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Singh H; Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Donoghue M; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland.
Clin Cancer Res ; 30(1): 23-28, 2024 01 05.
Article in En | MEDLINE | ID: mdl-37624421
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thiazoles Limits: Adult / Child / Humans Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2024 Type: Article
Fulltext
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PubMed Links
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Thiazoles Limits: Adult / Child / Humans Language: En Journal: Clin Cancer Res Journal subject: NEOPLASIAS Year: 2024 Type: Article