Tesaro is in strong position to win another regulatory victory for its drug Zejula, which could boost its standing in the market for PARP inhibitors to treat…

The FDA has ushered in a new era in lower cost cancer meds with its approval of Amgen’s Mvasi, a biosimilar of Roche’s blockbuster drug Avastin.

Mylan called Allergan's Restasis licensing agreement "desperate" and a "transparent" delay tactic in a federal court filing.

Stop worrying that Roche's Tecentriq might lose its bladder cancer nod. After talks with the FDA, the drugmaker says that threat has passed.

The FDA has issued a scathing warning letter to a Pfizer unit that produced EpiPens that failed during emergencies, some of them fatal.

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.

Pfizer’s acute myeloid leukemia drug Mylotarg is set to make its return.

Regulatory