The Swiss major’s partner Halozyme has revealed that the US launch for the subcutaneous version of the checkpoint inhibitor Tecentriq will be put back until 2024 following questions from the Food and Drug Administration about manufacturing processes.
A fortnight after celebrating the first global green light, in the UK, for the subcutaneous (SC) version of Tecentriq, Roche Holding AG's plans for a swift US approval for its anti-PD-L1 cancer immunotherapy have hit a bump in the regulatory road.
The US Food and Drug Administration had set a 15 September user fee goal date for the SC formulation of...
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
The US precision medicine company hopes its drug response predictor technology will enhance responses to the chemotherapy Ixempra on the basis of promising data from a handful of breast cancer patients in a Phase II trial, marking a positive turn in its journey to date.
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Pipelines in bioconjugates continue to develop, from ADCs to XDCs, with radionuclide drug conjugates (RDCs) and antibody-oligonucleotide conjugates (AOCs) leading the expansion.
Interim results from the Phase III REMARK study presented at WCLC showed the Chinese company’s second-generation ALK/ROS1 inhibitor met its primary endpoint as a first-line therapy in ALK-positive advanced NSCLC.
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