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Puma Biotechnology (PBYI)
NASDAQ:PBYI
Endocrine Therapy, Alisertib
Hormone Receptor Positive Her-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
Phase II
Recruiting
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
Apr 12, 2024
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Alisertib
Small Cell Lung Cancer
Phase II
Recruiting
A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer
Sep 27, 2023
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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 Puma Biotechnology (PBYI) have in its pipeline
PBYI is currently developing the following drugs: Endocrine Therapy, Alisertib, Alisertib. These drug candidates are in various stages of clinical development as the company works toward FDA approval.