Subependymal Giant Cell Astrocytoma
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FDA approval · 2024-04-30FDA Approved: EVEROLIMUS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Everolimus submitted by Hikma Pharmaceuticals USA Inc. This action updates approved labeling…
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FDA approval · 2021-10-18FDA Approved: EVEROLIMUS — Original Application (Par Health USA, LLC)
FDA approved Par Health USA, LLC's Original Application for EVEROLIMUS (a generic version of everolimus). The approval enables the generic p…
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FDA approval · 2021-02-11FDA Approved: EVEROLIMUS — Original Application (NorthStar RxLLC)
FDA approved NorthStar RxLLC's original application (ANDA) for Everolimus, a generic version of the mTOR inhibitor. The approval enables a g…
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FDA approval · 2020-06-08FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s generic Everolimus under an Original Application, enabling the sale of a generic version of th…
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FDA approval · 2020-02-13FDA Approved: AFINITOR — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application for Afinitor (everolimus) from Novartis Pharmaceuticals Corporation.
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CLINICAL_TRIALS trial_result · 2019-04-25Clinical Trial Update: Everolimus in Treating Patients With Recurrent Low-Grade Glioma [Phase 2]
Phase 2 clinical trial of everolimus in adults with recurrent low-grade glioma has completed; results were posted in 2019.
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FDA approval · 2018-04-12FDA Approved: EVEROLIMUS — Original Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s Original Application for Everolimus, establishing a generic version of the branded drug. The a…
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CLINICAL_TRIALS trial_result · 2015-06-15Clinical Trial Update: Erlotinib and Temsirolimus in Treating Patients With Recurrent Malignant Glioma [Phase 1, Phase 2]
This entry reports the completion and posted results of a Phase 1/2 trial evaluating erlotinib in combination with temsirolimus for recurren…
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CLINICAL_TRIALS trial_result · 2015-03-23Clinical Trial Update: Sunitinib Malate in Treating Younger Patients With Recurrent, Refractory, or Progressive Malignant Glioma or Ependymoma [Phase 2]
Phase 2 trial of sunitinib malate in children with recurrent, refractory, or progressive malignant gliomas and ependymomas has completed; re…
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CLINICAL_TRIALS trial_result · 2014-10-20Clinical Trial Update: Everolimus (RAD001) Therapy of Giant Cell Astrocytoma in Patients With Tuberous Sclerosis Complex [Phase 1, Phase 2]
This clinical trial update reports results for everolimus (RAD001) therapy of giant cell astrocytoma in patients with tuberous sclerosis com…
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FDA approval · 2014-07-01FDA Approved: AFINITOR DISPERZ — Supplemental Application (Novartis Pharmaceuticals Corporation)
FDA approved a supplemental application to add Afinitor Disperz, the dispersible tablet form of everolimus, expanding formulation options fo…
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CLINICAL_TRIALS trial_result · 2012-05-01Clinical Trial Update: Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1) [Phase 3]
Phase 3 EXIST-1 trial evaluating everolimus for subependymal giant cell astrocytoma in tuberous sclerosis complex demonstrates efficacy and …