Approvals
The FDA lifts its clinical hold on Ocugen’s COVID-19 vaccine, and Ocugen announces a clinical trial for the treatment of inherited retinal diseases.
The latest EUA adjustment was based on findings that Evusheld might not be as active against certain subvariants of Omicron, but it could be if the dosage is increased.
Eli Lilly’s Jardiance scores expanded heart failure approval from the FDA and will now be available to all patients with heart failure to reduce the risk of death and hospitalization.
The FDA’s decision to approve Purdue’s drug Nalmefene earned mixed reactions, especially as the company is in the middle of lawsuits. Here’s what you need to know.
With IND approval, the therapeutics have become the first LBPs for Parkinson’s disease cleared by the FDA.
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.
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.
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.
It’s not clear if the recent deaths reported in FAERS resulted from the patients taking Aduhelm. This article takes a deep dive into this controversy.
PRESS RELEASES