113 results on '"Donoghue, Martha"'
Search Results
2. The Role of Regulatory Agencies in Pediatric Cancer Drug Development
3. Paediatric Strategy Forum for medicinal product development of multi-targeted kinase inhibitors in bone sarcomas: ACCELERATE in collaboration with the European Medicines Agency with participation of the Food and Drug Administration
4. US Food and Drug Administration Approval Summary: Eflornithine for High-Risk Neuroblastoma After Prior Multiagent, Multimodality Therapy.
5. FDA regulatory considerations for the review of drugs intended to treat pediatric cancers and rare tumors
6. The Role of Regulatory Agencies in Pediatric Cancer Drug Development
7. Considering Functional Outcomes as Efficacy Endpoints in Pediatric Low-Grade Glioma Clinical Trials: An FDA Educational Symposium
8. Supplementary Table S1 from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
9. Data from FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
10. Review of Racial and Ethnic Representation of Participants Enrolled in Pediatric Clinical Trials of Oncology Drugs Conducted Through FDA Written Requests
11. Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols
12. FDA Approval Summary: Alpelisib for PIK3CA-Related Overgrowth Spectrum
13. FDA Approval Summary: Dabrafenib in combination with trametinib for BRAF V600E mutation-positive low-grade glioma
14. Statistical Considerations in Pediatric Cancer Trials: Report of American Statistical Association Biopharmaceutical Section Open Forum Discussions.
15. Transcriptomic analysis of pancreatic adenocarcinoma specimens obtained from Black and White patients
16. FDA Approval Summary: Pemigatinib for Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusion or Other Rearrangement
17. FDA Approval Summary: Mobocertinib for Metastatic Non–Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
18. FDA Approval Summary: Belzutifan for von Hippel-Lindau Disease–Associated Tumors
19. Association of progression-free survival and overall response rate with overall survival in first-line randomized trials of immune checkpoint inhibitor–based regimens for metastatic non–small cell lung cancer (NSCLC): An FDA pooled analysis.
20. Outcomes of anti–PD-(L)1 therapy with or without chemotherapy (chemo) for first-line (1L) treatment of advanced non–small cell lung cancer (NSCLC) with PD-L1 score ≥ 50%: FDA pooled analysis.
21. FDA analysis of expanded access use in pediatric patients from 2015 to 2020.
22. FDA Approval Summary: Nivolumab in Combination with Ipilimumab for the Treatment of Unresectable Malignant Pleural Mesothelioma
23. FDA Approval Summary: Pembrolizumab, Atezolizumab, and Cemiplimab-rwlc as Single Agents for First-Line Treatment of Advanced/Metastatic PD-L1–High NSCLC
24. Second Paediatric Strategy Forum for anaplastic lymphoma kinase (ALK) inhibition in paediatric malignancies
25. Subgroup Analyses in Oncology Trials: Regulatory Considerations and Case Examples
26. FDA Approval Summary: Nivolumab Plus Ipilimumab for the Treatment of Patients with Hepatocellular Carcinoma Previously Treated with Sorafenib
27. FDA Approval Summary: Pembrolizumab for the Treatment of Tumor Mutational Burden–High Solid Tumors
28. Development of Drugs for Pediatric Cancers
29. FDA Approval Summary: Entrectinib for the Treatment of NTRK gene Fusion Solid Tumors
30. FDA Oncology Center of Excellence Project Renewal: Engaging the Oncology Community to Update Product Labeling for Older Oncology Drugs
31. Benefit–Risk Summary of Nivolumab for the Treatment of Patients with Unresectable Advanced, Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma After Prior Fluoropyrimidine- and Platinum-Based Chemotherapy
32. Contributors
33. Fungal infections of the respiratory tract
34. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma
35. FDA Approval Summary: Atezolizumab Plus Bevacizumab for the Treatment of Patients with Advanced Unresectable or Metastatic Hepatocellular Carcinoma
36. Paediatric Strategy Forum for medicinal product development of epigenetic modifiers for children
37. Before It’s Too Late: Multistakeholder Perspectives on Compassionate Access to Investigational Drugs for Pediatric Patients With Cancer
38. ACCELERATE and European Medicines Agency Paediatric Strategy Forum for medicinal product development of checkpoint inhibitors for use in combination therapy in paediatric patients
39. Hyponatremic Seizure in a Child Using Desmopressin for Nocturnal Enuresis
40. FDA Supplemental Approval Summary: Lenvatinib for the Treatment of Unresectable Hepatocellular Carcinoma.
41. FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1
42. FDA Benefit-Risk Assessment of Osimertinib for the Treatment of Metastatic Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation
43. Modernizing Clinical Trial Eligibility: Recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Minimum Age Working Group
44. FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD‐L1.
45. Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials—Response
46. Focusing on Core Patient-Reported Outcomes in Cancer Clinical Trials: Symptomatic Adverse Events, Physical Function, and Disease-Related Symptoms
47. FDA Benefit‐Risk Assessment of Osimertinib for the Treatment of Metastatic Non‐Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor T790M Mutation.
48. Eribulin Mesylate for the Treatment of Patients with Refractory Metastatic Breast Cancer: Use of a “Physician's Choice” Control Arm in a Randomized Approval Trial
49. Effects of Immunomodulatory and Organism-Associated Molecules on the Permeability of anIn VitroBlood-Brain Barrier Model to Amphotericin B and Fluconazole
50. Effects of Immunomodulatory and Organism-Associated Molecules on the Permeability of an In VitroBlood-Brain Barrier Model to Amphotericin B and Fluconazole
Catalog
Books, media, physical & digital resources
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.