FDA approves J&J’s RYBREVANT for NSCLC treatment
Full approval for the RYBREVANT plus chemotherapy regimen is based on data from the Phase III PAPILLON study.
04 March 2024
04 March 2024
Full approval for the RYBREVANT plus chemotherapy regimen is based on data from the Phase III PAPILLON study.
CIMERLI is an approved biosimilar to the reference product LUCENTIS, indicated for the treatment of retinal diseases.
The US Food and Drug Administration (FDA) placed a partial clinical hold on HIV programme and a full hold on Covid-19 trials for CytoDyn’s monoclonal antibody, leronlimab.
The approval is based on results from the LUMMICAR STUDY 1, a Phase II clinical trial conducted in China.
The company’s key asset, FOG-001, is being analysed in a Phase I/II clinical trial for the treatment of solid tumours.
Venture financing for US-headquartered companies with innovator drugs peaked in 2021, by 104% to $20.7bn, which in turn saw many early-stage biotechs going public that year with inflated valuations.
In addition to r/r multiple myeloma, the biotech is evaluating the drug as a treatment for advanced solid tumours alongside Keytruda.
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