Rare disease biotech Ultragenyx has its first FDA nod in Mepsevii, an enzyme therapy expected to carry a high price to treat a tiny group of patients.
AstraZeneca is about to find out whether its third-to-market respiratory biologic can stand out from a crowd that includes rivals GSK and Teva.
Three major regulatory bodies – FDA, EMA and Health Canada – changed their guidelines to drug naming. How could these changes impact drug launch timelines?
If recent numbers—and a new doctor survey—are any indication, Tesaro's Zejula has the lead in ovarian cancer. But that could change.
Merck's antiviral business suffered some serious blows this year, but it now boasts a new product: Prevymis, a CMV fighter approved by the FDA on Thursday.
Roche's Alecensa nabbed a new FDA approval to treat first-line lung cancer, putting it on even footing with Pfizer's Xalkori and Novartis'…
Novartis is blazing ahead with its bid to take its CAR-T therapy Kymriah into new realms with a double-pronged application in Europe.
England's Cancer Drugs Fund will cover Roche's Tecentriq for bladder cancer after NICE rejected it for routine use.
Cutting-edge cell therapies from Novartis and Gilead aren't direct rivals for now, but with a new FDA filing, that could change—and soon.
Novartis' $3.9B deal for Advanced Accelerator Applications comes with a blockbuster-to-be, Lutathera, that could follow in Sandostatin's footsteps.
The CDC committee in charge of vaccination policy in the U.S. endorsed GlaxoSmithKline's Shingrix over the older shot, Merck's Zostavax.