FDA

News

Eli Lilly picks up a second FDA approval for IL-23 inhibitor Omvoh in Crohn's disease, but will it kickstart sales growth?

News

FDA has started its review of an autoinjector version of Eisai and Biogen's Alzheimer's drug Leqembi that could allow patients to be dosed at home.

News

The FDA has placed the credibility of AI's 'context of use' in pharma development at the heart of its first guidance in this area.

News

Novo Nordisk has asked the FDA to block compounders from making versions of its older, once-daily GLP-1 agonist liraglutide.

News

Capricor completes its US filing for deramiocel, vying to become the first FDA-approved therapy for cardiomyopathy in Duchenne muscular dystrophy.

News

The FDA has wrapped up a series of new approvals as 2024 draws to a close, with Novo Nordisk, Pfizer, Vertex, and Hikma among the beneficiaries.