The FDA has granted breakthrough therapy designation to Biogen’s litifilimab for CLE, a chronic autoimmune skin condition.
Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result that showed improvements in cutaneous ...
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, ...
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.
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 ...
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FDA to review Eisai’s Leqembi Iqlik sBLA for Alzheimer’s
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 ...
Eisai and Biogen recently announced that the U.S. FDA has accepted for Priority Review a supplemental Biologics License Application for LEQEMBI IQLIK, a subcutaneous weekly autoinjector starting dose ...
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with ...
Biogen Inc.’s new at-home Alzheimer’s drug will give the company an edge over rival Eli Lilly Co.’s competing therapy, its ...
Venture investors are adopting a more aggressive mindset heading into 2026, while Merck, Moderna and Summit are all approaching crucial trial readouts.
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for litifilimab (BIIB059) for the ...
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