regulatory approval
The agency acknowledges its staff can't keep up with the volume of cell and gene therapy products and is looking to PDUFA VII for additional funds.Â
NICE Recommends AstraZeneca's Imfinzi for PD-L1-Positive NSCLC
The agency recommended that NHS England make the immunotherapy available based on data from the Phase III PACIFIC trial.
Bristol Myers Squibb's Breyanzi Approved in Europe for Lymphoma Patients
The European Commission approved the autologous CAR T-cell therapy after reviewing data from the Phase I TRANSCEND NHL 001 study.
Xcovery's Ensartinib Approved for First-Line ALK-Positive NSCLC in China
The drug was previously approved in the country as a second-line treatment for ALK-positive non-small cell lung cancer patients.
Burning Rock Secures Lung Cancer NGS Test Regulatory Approval in China
The LungCure CDx next-gen sequencing kit is the company's second NMPA-approved in vitro diagnostic following a smaller six-gene panel commercialized in 2018.
Mar 30, 2021