Felzartamab
Graves' Disease
Phase II
Recruiting
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Jul 20, 2026
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Fingolimod, Dimethyl Fumarate, Diroximel Fumarate
Relapsing Forms Of Multiple Sclerosis
Phase III
Not Yet Recruiting
A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)
Feb 26, 2026
Felzartamab
Antibody-Mediated Rejection, Microvascular Inflammation
Phase III
Enrolling By Invitation
A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE)
Feb 26, 2026
Tofersen
Amyotrophic Lateral Sclerosis
Phase IV
Active Not Recruiting
A Study to Learn More About the Long-Term Safety of Tofersen (Qalsody) in Chinese Participants With SOD-1 Amyotrophic Lateral Sclerosis (ALS)
Oct 31, 2025
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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 Biogen (IDP) have in its pipeline
IDP is currently developing the following drugs: Felzartamab, Biib144, Fingolimod, Dimethyl Fumarate, Diroximel Fumarate. These drug candidates are in various stages of clinical development as the company works toward FDA approval.