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Filing Requirements Clinical Trials Food and Drug Administration (FDA)

Goodwin

Kashiv BioSciences Reports Positive Topline Results for XOLAIR® Biosimilar Candidate ADL-018

Goodwin on

On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria.  ...more

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

Hogan Lovells on

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

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