Most Oncologic Drugs Advisory Committee members took issue with the lack of dosing optimization and the lack of US patient ...

The FDA said the GSK drug shrank tumors in 41.6% of patients. Of those responders, 9.1% had a complete response while 32.5% showed a partial response. The median duration of response was 34.7 ...

FDA takes tougher line on fast-tracked drugs GSK, Roche pull drugs previously approved on an accelerated basis, while other firms win speedy approvals only after starting confirmatory studies ...