Drug Approval | June 27, 2022
Astellas’s update on the Fortis clinical trial of AT845 in adults for pompe disease
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
The FDA informed Astellas that it did not have sufficient information to assess the risks to subjects
Alliances with CVS Health and Javara further embed clinical research into the community healthcare setting, expanding access to patient populations across the U.S to increase diversity in clinical trials
First and only FDA-approved device of its kind demonstrates consistently high rates of target limb salvage and freedom from clinically-driven target lesion revascularization
Amarex Clinical Research guides its client to phase II of FDA trials
TAK-003 is currently undergoing regulatory review for potential licensure in both the European Union
Phase I trial in Rwanda and South Africa aims to evaluate mRNA HIV vaccine antigen for safety and immunogenicity and strengthen regional scientific capacity
Leading this effort was Cytel’s principal research scientist and Professor of Health Research Methods at McMaster University in Canada, Dr. Edward Mills
They are GQ1005, an ADC with an excellent bystander killing effect, and GQ1007, a first-in-class antibody-immune-agonist-conjugate (AIAC) both with global intellectual property rights
AKS-452 is currently undergoing Phase II/III clinical testing in India as a primary vaccine; submission for Emergency Use Authorization (EUA) expected by Q3 2022
SCG101 is an autologous T-cell receptor (TCR) T-cell therapy for liver cancer
Subscribe To Our Newsletter & Stay Updated
