How to Avoid The Dangers of Duplicate Participants in Clinical Trials
The prevalence of duplicate participants in clinical trials poses significant risks, compromising the integrity of data and the safety...
Datopotamab Deruxtecan BLA Accepted for US Lung Cancer
Daiichi Sankyo and AstraZeneca’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the U.S. FDA...
Tagrisso & Chemo Combo Approved in US for EGFR Lung Cancer
AstraZeneca’s TAGRISSO® (osimertinib), in combination with chemotherapy, has been approved in the US for the treatment of adult patients...
FDA OKs Xolair as Sole Drug for Multi-Food Allergies
Genentech, a member of the Roche Group, has announced the FDA approval of Xolair® (omalizumab) for reducing allergic reactions,...
How Practical Is FDA’s HCP Approach in DCTs?
The FDA’s latest guidance on Decentralized Clinical Trials (DCTs) marks a pivotal shift in the clinical research landscape. This...
Gilead Boosts Liver Portfolio by Acquiring CymaBay
Gilead Sciences, Inc. has agreed to acquire CymaBay Therapeutics, Inc. for $4.3 billion, expanding its portfolio with seladelpar, a...
Remarkable Advances in Liver Self-Transplantation Trials
Clinical trials in liver stem cell transplantation therapy represent a frontier in medical research, particularly for conditions like late-stage...
Takeda’s EoE Drug Eohilia Gets First FDA Approval in US
Takeda has announced that the U.S. Food and Drug Administration (FDA) has approved EOHILIA (budesonide oral suspension) for the...
Takeda’s TAK-861 Narcolepsy Phase 3 Trials Set for FY2024
Takeda has announced promising topline results from a Phase 2b trial evaluating TAK-861, an oral orexin receptor 2 (OX2R)...
Survey: Pharma Fears CRO Instability Amid Sector Mergers
Worldwide Clinical Trials has released a survey report on the perceptions of large and midsize contract research organizations (CROs)...