Novo Nordisk has settled, for nearly $60 million, a batch of lawsuits over past marketing of its Type 2 diabetes drug Victoza.  

Mylan and Biocon, whose Herceptin biosimilar was to be considered by the FDA Sept. 3, has had its target date delayed three months.

Representatives from several groups asked the FDA to consider pulling powerful opioids from the market.

Novartis's groundbreaking CAR-T med won FDA approval Wednesday, but debate over pricing—and the company's responses—are just beginning.

Doctors treating complicated urinary tract infections will soon have a new tool in their arsenal with the FDA’s Tuesday approval for Vabomere.

The FDA approved Chagas medication benznidazole from collaborators Chemo Group, Mundo Sano and DNDi.

As part of a crackdown on stem cell clinics, the FDA found an operation using Sanofi's smallpox vaccine in an illegitimate cancer therapy.

AstraZeneca may have recently hit a snag in the immuno-oncology space, but it got a boost Monday elsewhere in its cancer portfolio.

Regulatory