Natasha T. Metzler

A federal district court ruled that FDA cannot fail to rule on a Sandoz's application for approval of omnitrope, a human growth hormone, just because it has no policy for generic biologics. Court watchers say the decision may help other generic biologics move forward in the approvals process.

A new study details the physiological reasons why COX-2 inhibitorsincrease the risk of heart disease. Suppressing the production of one key fact does reduce pain, but it also deprives the body of a mechanism to curb blood clots, resist artery hardening, and regulate blood pressure.

Psychiatrists offer insight on the second phase of results from a National Institutes of Health study comparing different anti-psychotic drugs.

Industry experts weigh in on what could be the resolution of a long saga.

New research shows that travel to and from work is important in spreading influenza from city to city and state to state.

A new study indicates that a protein produced by HIV invades uninfected B cells and inhibits a mechanism that makes certain antibodies very good at targeting invading agents.

Experts say proposed label changes or black box warnings would not significantly decrease ADHD drug prescriptions. But they see potential market opportunities for new products and generics.

The high court could fine-tune the definition of what is patentable in deciding LabCorp v. Metabolite. Legal experts weigh-in on the nuances of the case.

The recommendation shows traditional risk-benefit analysis is still working, experts say. But they also believe the Tysabri saga illustrates a trend towards increased use of advisory committees and requirements for drug mechanism data.