FDA panel

AstraZeneca's Heart Drug Brilinta: The FDA Is Ready to Rule

More than a year after AstraZeneca filed for approval of its heart drug Brilinta, the FDA will make its decision on Thursday. A large study showed the blood thinner worked better than Plavix for treating acute coronary syndrome -- but approval isn't a sure thing, due in part to some oddities in the study's results.

Pharma News Briefs: Human Genome, Merck, Novartis

Here's a roundup of some of Wednesday's major pharmaceutical news: An FDA panel gave Human Genome Sciences a boost with a thumbs-up for its lupus drug, Benlysta; Merck's experimental heart drug appears to work well without side effects; and Novartis announced its plans for long-term growth.

How to Approve 'Biosimilar' Drugs? The FDA Has to Figure That Out

Unlike generics, which are the exact chemical copies of a brand-name drug, biosimilars have large and often complex proteins that are made in living cells, and tiny differences can play havoc with the product. It may take years for the FDA to create an approval process.

Jazz Shares Fall After FDA Panel Rejects Fibromyalgia Drug

Share of Jazz Pharmaceuticals shares sank over 24% in early morning trading Monday after an FDA advisory panel rejected its proposed fibromyalgia drug, Xyrem, Friday. Though Xyrem appeared to help some patients, the panel found the benefits didn't outweigh the risks.