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RGT-419B Alone or With Hormone Therapy in HR+/HER2- Advanced Breast Cancer

Researchers are conducting a phase 1 trial to evaluate RGT-419B, a CDK2/4/6 inhibitor, in patients with HR+, HER2-, stage III/IV breast cancer. ....

Marjorie Zettler , Regor Pharmaceuticals Inc , Regor Pharmaceuticals ,

FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion. ....

United States , Marjoriee Zettler , Le Tourneau , Drug Administration , Regor Pharmaceuticals Inc , Research To Accelerate Cures , Regor Pharmaceuticals , Accelerate Cures , Children Act , States Food , Expansion Cohorts , First In Human Clinical Trials , Expedite Development , Oncology Drugs , Study Evaluating , Subjects With Solid Tumors , Adults With Non Small Cell Lung , Human Bispecific , Met Antibody , Patients With Thyroid Cancer , Non Small Cell Lung Cancer , Participants With Advanced Solid Tumors , Positive Solid Tumors , Medullary Thyroid Cancer , Older Adults , Cancer Clinical ,

FDA Issues Guidance On Expansion Cohorts In Clinical Trials Of Oncology Drugs

The FDA issued the final guidance document for first-in-human trial designs that consist of both dose escalation as well as multiple expansion. ....

United States , Marjoriee Zettler , Le Tourneau , Drug Administration , Regor Pharmaceuticals Inc , Research To Accelerate Cures , Regor Pharmaceuticals , Accelerate Cures , Children Act , States Food , Expansion Cohorts , First In Human Clinical Trials , Expedite Development , Oncology Drugs , Study Evaluating , Subjects With Solid Tumors , Adults With Non Small Cell Lung , Human Bispecific , Met Antibody , Patients With Thyroid Cancer , Non Small Cell Lung Cancer , Participants With Advanced Solid Tumors , Positive Solid Tumors , Medullary Thyroid Cancer , Older Adults , Cancer Clinical ,

3 Ways The FDA Is Taking Action On Lack Of Diversity In Cancer Clinical Trials

Beyond issuing guidance documents, what actions has the FDA taken to ensure inclusion of relevant patient populations in cancer clinical trials? And. ....

United States , Marjoriee Zettler , Richard Pazdur , Innovent Biologics Suzhou Co Ltd , Oncology Center , Drug Administration , Oncologic Drugs Advisory Committee Meeting , Regor Pharmaceuticals Inc , Research To Accelerate Cures , Oncologic Drugs Advisory Committee , Incyte Corporation , Regor Pharmaceuticals , Marketing Requirements , Request Data On Broader Patient , Cancer Clinical Trial Eligibility Criteria , Minimum Age Considerations , Adolescent Patients , Adult Oncology Clinical , Hematologic Malignancies Approval Notifications , Accelerate Cures , Children Act , Project Equity , Project Silver , Grace Reporting , Clinical Trials Leading , Cancer Drug Approvals From ,

3 Ways The FDA Is Taking Action On Lack Of Diversity In Cancer Clinical Trials

Beyond issuing guidance documents, what actions has the FDA taken to ensure inclusion of relevant patient populations in cancer clinical trials? And. ....

United States , Marjoriee Zettler , Richard Pazdur , Innovent Biologics Suzhou Co Ltd , Oncology Center , Drug Administration , Oncologic Drugs Advisory Committee Meeting , Regor Pharmaceuticals Inc , Research To Accelerate Cures , Oncologic Drugs Advisory Committee , Incyte Corporation , Regor Pharmaceuticals , Marketing Requirements , Request Data On Broader Patient , Cancer Clinical Trial Eligibility Criteria , Minimum Age Considerations , Adolescent Patients , Adult Oncology Clinical , Hematologic Malignancies Approval Notifications , Accelerate Cures , Children Act , Project Equity , Project Silver , Grace Reporting , Clinical Trials Leading , Cancer Drug Approvals From ,