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Boston Scientific (DE:BSX)
XETRA:BSX
Agent Dcb 40 Mm
In-Stent Restenosis
Phase III
Active Not Recruiting
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR) - Long Lesion Cohort
Jul 01, 2024
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Therasphere Gbm
Glioblastoma Multiforme, Recurrent Glioblastoma
Phase I
Recruiting
A Feasibility Study to Evaluate the Safety of the TheraSphere Glioblastoma (GBM) Device in Patients With Recurrent GBM
Mar 10, 2022
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Therasphere Y-90 Glass Microsphere Therapy, Durvalumab (Imfinzi) Immunotherapy, Tremelimumab Immunotherapy
Hepatocellular Carcinoma
Phase II
Active Not Recruiting
TheraSphere With Durvalumab and Tremelimumab for HCC
Sep 01, 2021
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Therasphere™ Yttrium-90 Glass Microspheres, Conventional Transarterial Chemoembolization(Ctace)
Inoperable Hepatocellular Carcinoma
Phase III
Active Not Recruiting
MANDARIN (S6371)
Aug 09, 2021
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Ekosonictm Endovascular System, Anticoagulation With Heparin
Pulmonary Embolism
Phase IV
Active Not Recruiting
Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism
Mar 02, 2021
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Agent Dcb, Ptca Balloon Catheter
In-Stent Restenosis
Phase III
Active Not Recruiting
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
Nov 23, 2020
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Deep Brain Stimulation
Idiopathic Parkinson's Disease
Phase II
Completed
Vercise Implantable Stimulator for Treating Parkinson's Disease
Oct 08, 2010
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Boston Scientific (BSX) have in its pipeline
BSX is currently developing the following drugs: Agent Dcb 40 Mm, Therasphere Gbm, Therasphere Y-90 Glass Microsphere Therapy, Durvalumab (Imfinzi) Immunotherapy, Tremelimumab Immunotherapy. These drug candidates are in various stages of clinical development as the company works toward FDA approval.