BIIB secures FDA's Breakthrough Therapy status for litifilimab in cutaneous lupus, backed by phase II results, while ...

The Phase III AMETHYST study is currently assessing litifilimab’s safety and efficacy, with results anticipated in 2027.

Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous ...

The FDA has granted breakthrough therapy designation for litifilimab in patients with cutaneous lupus erythematosus, according to a press release from manufacturer Biogen. Litifilimab (Biogen) is a ...

Biogen's CEO says the company's late-stage pipeline is in good shape, but the drugmaker is still hunting for deals to build out its early-stage research — good news for biotechs looking to partner.

Biogen has won U.S. Food and Drug Administration breakthrough-therapy designation for its litifilimab drug candidate for the treatment of the chronic autoimmune disease cutaneous lupus erythematosus, ...

During the first day of the 44 th Annual JP Morgan Healthcare Conference in San Francisco, a clear narrative emerged. With the looming patent cliff, companies are focused on their pipelines and making ...

The FDA has set a Prescription Drug User Fee Act action date for 24 May 2026.

Recent performance snapshot Biogen (BIIB) shares closed at US$171.59, with performance mixed across recent periods. The stock ...

Biogen Inc.’s new at-home Alzheimer’s drug will give the company an edge over rival Eli Lilly Co.’s competing therapy, its chief executive officer said in an interview.

Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision ...

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for litifilimab (BIIB059) for the ...