Samsung Bioepis has taken a big step toward approval for a Herceptin biosim in Europe.
Armed with a new cardiovascular benefit nod, Novo Nordisk’s diabetes fighter Victoza has a better shot at fighting off newer rivals.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
Novartis’ Kisqali is playing from behind. But it just may have a shot at being No. 1 when it comes to snagging reimbursement in England.
Sorry, Tesaro. AZ's Lynparza won a broader-than-expected approval in ovarian cancer, putting it on even footing with Tesaro’s recent launch, Zejula.…
Eli Lilly’s RA med baricitinib had been pegged as one of 2017’s hottest launches—and a threat to Pfizer’s Xeljanz. Not anymore.
Purdue, which has been fending off lawsuits over pain drug OxyContin in the U.S., may have to face off against Canada’s federal government.
Opioid makers face a task that’s partly old, partly new. Besides training docs on their meds' risks, they'd have to include info on rival therapies.
Transparency hasn't made much of a difference when it comes to drug and device makers' payments to doctors, which amounted to $2.6 billion last year.
Shire nabbed FDA approval Wednesday for its new long-acting ADHD drug Mydayis, and it's targeting $500 million in sales by 2020.
With biologics dominating its pipeline, Sanofi will spend as much as $2 billion on its biologics manufacturing network over the next several years.