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Rallybio (RLYB)
NASDAQ:RLYB
Rlyb116 For Injection
Autoimmune Diseases, Hematologic Diseases
Phase I
Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of RLYB116 in Healthy Participants
Jan 22, 2025
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Anti-(Integrin Beta-3) Human Monoclonal Antibody
Fetal And Neonatal Alloimmune Thrombocytopenia
Phase II
Active Not Recruiting
Phase 2 Study on the Pharmacokinetics and Safety of RLYB212 in Pregnant Women at Higher Risk for HPA-1a Alloimmunization
May 21, 2024
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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 Rallybio (RLYB) have in its pipeline
RLYB is currently developing the following drugs: Rlyb116 For Injection, Anti-(Integrin Beta-3) Human Monoclonal Antibody. These drug candidates are in various stages of clinical development as the company works toward FDA approval.