Regulatory
It is unknown whether tightening economic sanctions will limit Russia’s ability to ship its vaccines to areas that do not have strong manufacturing capabilities.
Studies from Guttmacher Institute found that 54% of all abortions in the United States in 2020 were done with pills instead of surgery, an increase from approximately 44% in 2019.
Not only is this the first approval for a plant-based vaccine, it’s also the first approval for GSK’s adjuvant.
AstraZeneca and Sanofi secured accelerated authorization for respiratory syncytial virus (RSV) antibody nirsevimab from the European Medicines Agency.
The U.S. Centers for Disease Control and Prevention is under fire for failing to publish large swaths of hospitalization data related to the COVID-19 pandemic.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Patient enrollment for the clinical trial, which was testing Atara’s autologous chimeric antigen receptor (CAR) T-cell immunology therapy called ATA2271, has been paused.
After roaring into February with positive data in five different indications, Regeneron and Sanofi announced today a late-stage Dupixent trial has been halted due to futility.
Bayer is heading back to the FDA to seek approval for a new indication of its prostate cancer drug Nubeqa, following positive Phase III results.
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