Approvals
The FDA rejected Gilead’s New Drug Application, citing Chemistry Manufacturing and Controls (CMC) problems associated with the compatibility of the drug with the proposed container vial.
In 2021, Sanofi earned about $4.2 billion from Dupixent sales, and Regeneron earned about $1.8 billion.
Johnson & Johnson’s partner, Legend Biotech, has been awarded FDA approval for its (CAR-T) therapy, Carvykti, for the treatment of multiple myeloma disease.
The FDA declined approval for Amryt Pharma’s therapeutic oleogel-S10. The topical gel is intended to treat a group of rare skin diseases called epidermolysis bullosa.
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.
PRESS RELEASES