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Fluticasone Furoate And Vilanterol Inhalation Powder, Breo Ellipta
Respiratory
Phase III
Not Yet Recruiting
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
Oct 15, 2025
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Jpb898 (Induction And Maintenance), Opdivo-Eu (Induction), Opdivo-Us (Induction), Yervoy-Eu (Induction), Opdivo-Eu (Maintenance)
Melanoma
Phase III
Suspended
Integrated Pharmacokinetics (PK)/Efficacy, Safety, and Immunogenicity Study to Demonstrate Similarity of JPB898, a Proposed Biosimilar to Nivolumab, to Opdivo® in Combination With Yervoy®
Aug 30, 2024
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Gme751, Keytruda-Eu
Metastatic Nsclc
Phase III
Suspended
A Study to Compare Efficacy, Safety, and Immunogenicity of GME751 and EU-authorized Keytruda in Adult Participants With Untreated Metastatic Non-squamous Non-small Cell Lung Cancer (NSCLC)
Oct 10, 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 Sandoz Group Ltd (SDZ) have in its pipeline
SDZ is currently developing the following drugs: Fluticasone Furoate And Vilanterol Inhalation Powder, Breo Ellipta, Cyb704, Ocrevus-Eu, Ocrevus-Us, Jpb898 (Induction And Maintenance), Opdivo-Eu (Induction), Opdivo-Us (Induction), Yervoy-Eu (Induction), Opdivo-Eu (Maintenance). These drug candidates are in various stages of clinical development as the company works toward FDA approval.