Weekly Digest 2 Feb 2024

Regulatory  ·  Weekly Digest 2 Feb 2024
FDA Fast Track for BioNTech & DualityBio’s Next-Gen ADC BNT325/DB-1305

Weekly Digest – Feb 2024 Weekly Digest – Feb 2024 31 Jan 2024: FDA Fast Track Designation for BioNTech & DualityBio’s Next-Gen ADC BNT325/DB-1305 BioNTech and DualityBio have received FDA Fast Track designation for their next-generation antibody-drug conjugate (ADC) BNT325/DB-1305, […]

by Sandhya Ramalingam

Continue Reading
Regulatory  ·  Weekly Digest 2 Feb 2024
Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors

Weekly Digest – Feb 2024 Weekly Digest – Feb 2024 29 Jan 2024: Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors The application is based on results from the DESTINY-PanTumor02 trial and supported by additional […]

by Sandhya Ramalingam

Continue Reading