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Clinical trial updates in cancer care include a remote study in small cell lung cancer and new findings in ovarian, solid ...
Autonomix Medical (Nasdaq:AMIX) announced today that it advanced its proprietary sensing catheter through a final design ...
In this video interview, Meri Beckwith, Co-CEO of Lindus Health, discusses recent Complete Response Letters issued to Replimune and Capricor, explaining how shifts in FDA reviewers can affect ...
Pfizer Inc (($PFE)) announced an update on their ongoing clinical study. Pfizer Inc. is conducting a Phase 3 clinical trial titled ‘Randomized ...
Amgen Inc (($AMGN)) announced an update on their ongoing clinical study. Amgen Inc. is conducting a Phase 3 clinical study titled ‘A Phase 3, ...
Urteste S.A. Completes Development of Panuri Test – Company Plans to Launch Clinical Study in Q3 2025 Provided by GlobeNewswire Jul 21, 2025, 5:14:07 AM ...
Improving Protocol Design with RWD Protocol design is the backbone of any clinical trial, outlining study objectives, patient selection criteria, endpoints, and procedures.
On May 31, 2024, the FDA announced initiation of the Support for Clinical Trials Advancing Rare Disease Therapeutics (“START”) pilot program. The START program, led by the Center for Biologics ...
Pfizer's presentation at the 2025 ASCO Annual Meeting will provide further insights into the trial design. Additional details on the study can be found at ClinicalTrials.gov (NCT06466187).
“We appreciate the partnership with the FDA as we aligned on the key elements of our NGN-401 registrational trial design, which will allow for rapid conversion of the current Phase 1/2 study to ...
In part 1 of this article, we offer a framework for fit-for-purpose study design and data source selection in the context of Medicare “coverage with evidence development“ (CED). In part 2, we ...