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.

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.

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

Novartis nabbed its anticipated FDA nod for CAR-T treatment tisagenlecleucel, a first-ever cell therapy, to be marketed as Kymriah.

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.

Regulatory