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PDS Biotechnology Corporation (PDSB)
NASDAQ:PDSB
Combination Treatment Of Pds0101 And Pembrolizumab, Pembrolizumab Monotherapy
Hpv Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head And Neck, Metastatic Head And Neck Cancer, Recurrent Head And Neck Cancer, Unresectable Head And Neck Squamous Cell Carcinoma
Phase III
Recruiting
Phase 3 Study of PDS0101 and Pembrolizumab in HPV16+ Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Jan 14, 2025
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Pembrolizumab (Keytruda®) And Pds0101
Hpv Positive Oropharyngeal Squamous Cell Carcinoma, Neoplasms, Head And Neck, Metastatic Head And Neck Cancer, Recurrent Head And Neck Cancer
Phase II
Completed
Study of PDS0101 and Pembrolizumab Combination I/O in Subjects With HPV16 + Recurrent and/or Metastatic HNSCC
Feb 05, 2020
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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 PDS Biotechnology Corporation (PDSB) have in its pipeline
PDSB is currently developing the following drugs: Combination Treatment Of Pds0101 And Pembrolizumab, Pembrolizumab Monotherapy, Pembrolizumab (Keytruda®) And Pds0101. These drug candidates are in various stages of clinical development as the company works toward FDA approval.