While FDA action dates may have come and gone on some biosimilar applications, known as 351(k)s, it would be wrong to make an assumption regulators had issued a complete response letter (CRL) due to the lack of biosimilarity, warned Leah Christl, associate director for therapeutic biologics.
While FDA action dates may have come and gone on some biosimilar applications, known as 351(k)s, it would be wrong to make an assumption regulators had issued a complete response letter (CRL) due to the lack of biosimilarity, warned Leah Christl, associate director for therapeutic biologics.
"As a general matter, for any application, there's a number of things that could create a bump in the road,"...
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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