Weekly Digest – August 2024 Weekly Digest – August 2024 20 Aug 2024: FDA greenlights BioNTech/Medilink’s cancer trial at lower dose after deaths The FDA has allowed BioNTech and Medilink to resume their Phase I oncology trial of BNT326/YL202, a […]
Weekly Digest – August 2024 Weekly Digest – August 2024 20 Aug 2024: GSK5764227 Gains FDA Breakthrough Therapy Designation in ES-SCLC The FDA has granted breakthrough therapy designation to GSK5764227, a B7-H3–targeted antibody-drug conjugate, for treating extensive-stage small cell lung […]
Weekly Digest – August 2024 Weekly Digest – August 2024 19 Aug 2024: ENHERTU® Granted Breakthrough Therapy Designation in U.S. for Certain Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer ENHERTU® has been granted Breakthrough Therapy Designation in the U.S. […]
Weekly Digest – August 2024 Weekly Digest – August 2024 19 Aug 2024: ENHERTU® Type II Variation Application Validated by EMA for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Following At Least One Endocrine Therapy The European Medicines […]
