https://www.fiercebiotech.com/biotech/fda-under-fire-over-accelerated-approval-data-demands
Researchers have raised concerns about the level of evidence needed to win accelerated approval from the FDA.
under fireaccelerated approvalfdadatademands
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-dabrafenib-combination-trametinib-unresectable-or-metastatic-solid?sf166541819=1
FDA grants accelerated approval to dabrafenib in combination with trametinib for unresectable or metastatic solid tumors with BRAF V600E mutation
accelerated approvalin combinationfdagrantsdabrafenib
https://www.fiercebiotech.com/biotech/fda-outlines-draft-policy-mrd-complete-response-accelerated-approvals-multiple-myeloma
The guidance provides recommendations for designing clinical trials that use MRD or CR as endpoints for accelerated approval in multiple myeloma.
accelerated approvalfdaoutlinesdraftpolicy
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-encorafenib-cetuximab-and-mfolfox6-metastatic-colorectal-cancer-braf
The Food and Drug Administration granted accelerated approval to encorafenib (Braftovi, Array BioPharma Inc., a subsidiary of Pfizer Inc.) with cetuximab and...
accelerated approvalfdagrantsencorafenibcetuximab
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selpercatinib-pediatric-patients-two-years-and-older-ret-altered
On May 29, 2024, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for pediatric patients two...
accelerated approvalfdagrantsselpercatinibpediatric