Phase III
Weeks after announcing that its lead monoclonal antibody was demonstrating efficacy against the Omicron variant, Adagio Therapeutics CEO Tillman Gerngross steps down.
Synairgen watched its stock plummet 85% after reporting disappointing Phase III results for its inhaled COVID-19 treatment on Feb. 21.
A new packaging and labeling manufacturing facility has derailed the potential approval of Malinckrodt’s investigational hepatorenal syndrome (HRS) treatment, terlipressin.
AstraZeneca and Daiichi Sankyo released positive data from their Phase III trial of Enhertu. An alternative to chemotherapy for some HER2 low breast cancer.
The end of February picks up significantly from early this year for the U.S. Food and Drug Administration and its PDUFA dates.
Clinical Catch-Up for February 21
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.
GlaxoSmithKline has voluntarily paused activities in its Phase III GRACE trial on a candidate maternal vaccine for respiratory syncytial virus.
The FDA has approved Agios Pharmaceuticals’ Pyrukynd for a rare type of hemolytic anemia treatment. Continue reading the article to know more about the new drug.
PRESS RELEASES