The new platform combines seven different adverse event dashboards into one, an effort that could save the agency $120 million over five years, it said.

According to a new team-up between Eisai and Pokémon, when it comes to healthy sleep habits, people of all ages have gotta catch ’em all.

While much of the company’s recent focus has remained on beefing up its U.S. infrastructure, Eli Lilly has for the second time this week made moves to raise capacity for its medicines overseas, and once again in Asia.

Eli Lilly—which has already staged multiple efforts in court to protect sales of its diabetes and obesity meds Mounjaro and Zepbound from compounders—is launching a new salvo focused on the potential safety risks behind a common compounding tactic.

The rare disease field is navigating a period of significant turbulence, what with a “temperamental” FDA and competition for investor attention from mainstream blockbusters like obesity treatments. Yet, despite the “stormy waters,” global sales of orphan drugs are projected to exceed $400 billion by 2032, according to a new report […]

A panel of physicians, biotech leaders and patient advocates took aim at the FDA during a Senate hearing on how the agency’s bureaucracy affects innovation.