Enhertu has now been granted five Breakthrough Therapy Designations, including three in breast cancer and one in both lung and gastric cancers
An RMAT confers eligibility for accelerated approval and priority review of biologics licensing applications (BLA)
The company plans to file its NDA in China and MAA in the EU in 2022, making Hansizhuang potentially to be the world's first PD-1 inhibitor for the first-line treatment of SCLC
The FDA decision is primarily informed by the positive results of a proof-of-concept, Phase 2a study evaluating the safety, immunogenicity, and efficacy of a single dose of 120µg RSVpreF in a human viral challenge model in healthy adults 18 to 50 years of age
SIFI is currently evaluating various options for the commercialization of Akantior (polihexanide) globally, including potential out-license agreements outside its core markets
The NMPA Breakthrough Therapy Designation was based on results from the Phase 2 TRUST trial of ROS1 fusion-positive NSCLC patients treated with taletrectinib, a new generation of potent ROS1 inhibitors
Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases
Phase 2a clinical proof-of-concept biomarker study for PXL065 in ALD now anticipated to start midyear
The device will facilitate the treatment of cerebral vasospasm following hemorrhagic stroke
Last year, the company's early-stage breast cancer detection test became the first such test to receive the Breakthrough Device Designation
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