Bracing for generic rivals to its top-selling Advair—and looking to fill the sales gap—GSK nabbed FDA approval for its new respiratory med, Trelegy.

Keytruda's stumble in multiple myeloma has prompted the FDA to halt recruitment in Roche's Tecentriq tests in that cancer.

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.

Analysts think Regeneron and Sanofi’s injected immunology drug Dupixent could face some tough competition from easier-to-take JAK inhibitors.

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

Regulatory