Assessing the Impacts of the Prescription Drug User Fee Acts (PDUFA) on the FDA Approval Process [PDF]
, 2005 Ernst R. Berndt +3 more
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Molecular Oncology, EarlyView.Microglia (BV2) and IL‐4‐treated BMDMs promote astrocytoma clustering and inhibit tumor growth, not shown in other macrophage cells. In vivo, microglial co‐implantation enhances CD8+ T cell infiltration, elevates Granzyme B, lowers circulating MDSCs, and extends survival only in immune‐competent mice, but not in immune‐deficient mice.
Tzu‐Chieh Sun +5 more
wiley +1 more source
Conditional Drug Approval as a Path to Market for Oncology Drugs in Canada: Challenges and Recommendations for Assessing Eligibility and Regulatory Responsiveness. [PDF]
Front Med (Lausanne), 2021 McPhail M, Weiss E, Bubela T.
europepmc +1 more source
Drug approval system questioned in US and Canada [PDF]
, 2005 Laura Eggertson
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Bridging the gap: Multi‐stakeholder perspectives of molecular diagnostics in oncology
Molecular Oncology, EarlyView.Although molecular diagnostics is transforming cancer care, implementing novel technologies remains challenging. This study identifies unmet needs and technology requirements through a two‐step stakeholder involvement. Liquid biopsies for monitoring applications and predictive biomarker testing emerge as key unmet needs. Technology requirements vary by
Jorine Arnouts +8 more
wiley +1 more source
Advances on anticancer new drugs in China and the USA in 2020: from ongoing trial to drug approval. [PDF]
J Natl Cancer Cent, 2021 Huang H +10 more
europepmc +1 more source
US drug companies will meet more than half the cost of drug approval
, 2002 D. Josefson
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United States Food and Drug Administration Approval Summary: Bortezomib for the Treatment of Progressive Multiple Myeloma after One Prior Therapy [PDF]
, 2006 Robert C. Kane +3 more
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Molecular Oncology, EarlyView.Loss‐of‐function mutations in the scaffold subunit of protein phosphatase 2A (PP2A), PPP2R1A, sensitize ovarian clear cell carcinoma to immune checkpoint blockade (ICB) by enhancing the interferon gamma response and promoting antitumor immune cell infiltration.
Matheus Henrique Dias, René Bernards
wiley +1 more source
Current guidelines applicable for the approval of dermatological drugs
, 2002 A Zesch
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