FDA On Clinical Trial Innovation and Regulatory Evolution
The Enhancing Adoption of Innovative Clinical Trial Approaches: FDA Convening conference hosted by Duke Margolis Institute for Health Policy,...
EC Approves Bristol Myers’ Reblozyl as First-Line Treatment for LR-MDS Anemia
The European Commission (EC) has expanded approval of Reblozyl (luspatercept), a first-in-class treatment for patients with disease-related anemia, for...
D&D Pharmatech Receives Fast Track Designation from FDA for DD01 – Novel Treatment for NASH/MASH
D&D Pharmatech, a biotech company, has been granted Fast Track designation by the US Food and Drug Administration (FDA)...
EMA Accepts Rocket Pharma’s RP-L102 Application for Fanconi Anemia Treatment
Rocket Pharmaceuticals, a late-stage biotechnology company, has announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization...
US FDA Accepts Astrazeneca License Application for Datopotamab Deruxtecan in Metastatic HR+, HER2- Breast Cancer
Biopharmaceutical companies AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted in the US,...
VBI Vaccines Boosts Strategic Partnership to Propel MRNA-Launched EVLP Vaccine Platform
Biopharmaceutical firm VBI Vaccines has expanded its collaboration with the Canadian government, with the latter contributing the remaining CAD$28...
QLS-111 by Qlaris Bio Enters Phase II Trials for IOP Reduction
Qlaris Bio, Inc., a biotechnology firm focusing on ophthalmic diseases, has announced the initiation of two Phase II clinical...
Mirum’s Livmarli Gets Positive CADTH Reimbursement Nod for Alagille Syndrome in Canada
The Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee (CDEC) has issued a positive...
Merck’s Approach to Protocol Development: Building with Purpose:
At the 2024 SCOPE Summit, Laura Galuchie, Senior Director and TransCelerate Program Lead at Merck provided a fresh perspective...
Unlocking New Digital Health Technology in Clinical Trials
In the rapidly evolving landscape of digital health technology in clinical trials (DHT), Jeremy Wyatt, CEO of ActiGraph, envisions...