BioPharma Accord, Inc. reports the U.S. FDA has greenlit their application for a license regarding their proposed biosimilar to STELARA®, named DMB-3115.
Upon trial completion, the supervisor will retrieve the original case report form's first page, followed by data entry into the database for statistical analysis by the biostatistician per the pre-trial plan.
According to the tenets of the declaration of Helsinki, subjects can withdraw from the trial at any time according to their own wishes without any reason.
D2 receptor antagonists are drugs that block the D2 subtype of dopamine receptors, used in treating conditions like schizophrenia and bipolar disorder.
KYV-101, a therapeutic agent by Kyverna, has been granted approval by the American FDA for use in a Phase 2 study, KYSA-7, targeting individuals suffering from advanced, treatment-resistant Multiple Sclerosis.
To safeguard participant privacy in the clinical trial, only initials—rather than full names—should be used in trial documents, particularly those submitted to the sponsor.