Gilead Halts Development of Magrolimab in Hematologic Cancers Due to Increased Death Risk, Futility
February 8th 2024The FDA placed a full clinical hold on magrolimab for hematologic cancers after data showed the drug in combination with azacitidine plus Venclexta increased the risk of death related to infections and respiratory failure in patients with acute myeloid leukemia.
Regulatory Submissions Filed for Opdivo Regimen in Resectable Non-Small Cell Lung Cancer
February 7th 2024Phase III CheckMate -77T trial data show statistically significant improvements in event-free survival with Opdivo (nivolumab) plus chemotherapy followed by surgery and adjuvant Opdivo in the treatment of resectable stage IIA to IIIB non-small cell lung cancer.
FDA Grants Fast Track Designation to Cancer Vaccine for Malignant Pleural Mesothelioma
February 5th 2024UV1 is an off-the-shelf vaccine that has demonstrated a survival benefit in combination with ipilimumab (Yervoy) and nivolumab (Opdivo) in patients with unresectable malignant pleural mesothelioma.
Sanofi, AstraZeneca Launch Program to Mitigate Future RSV Vaccine Shortages
February 2nd 2024New reservation program for Beyfortus (nirsevimab-alip) seeks to improve access to the monoclonal antibody that is FDA-approved to protect against respiratory syncytial virus-associated lower respiratory tract disease.