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Last updated about 12 hours ago

FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic, HR-positive, HER2-negative breast cancer

about 14 hours ago

On January 17, 2025, the Food and Drug Administration approved datopotamab deruxtecan-dlnk...

FDA D.I.S.C.O. Burst Edition: FDA approval of Ryoncil (remestemcel-L-rknd) for steroid-refractory acute graft versus host disease in pediatric patients

about 14 hours ago

Listen to a soundcast of the 12.18.2024 FDA approval of Ryoncil (remestemcel-L-rknd)...

Drug Development and Drug Interactions | Resources

about 17 hours ago

Possible models for decision making, advisory committee meetings, presentations, preventable adverse reactions

Drug Development and Drug Interactions: Advisory Committee Meetings

about 17 hours ago

Drug Development and Drug Interactions: Advisory Committee Meetings

Drug Interaction Presentations

about 17 hours ago

Drug Interaction Presentations

Verified Clinical Benefit | Cancer Accelerated Approvals

about 17 hours ago

This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications...

Guidances | Drugs

about 19 hours ago

Newly added and withdrawn guidances can be found at Guidances (Drugs). FDA...

CDER Guidance Agenda

about 19 hours ago

CDER Guidance Agenda

FDA approves sotorasib with panitumumab for KRAS G12C-mutated colorectal cancer

1 day ago

On January 15, 2025, the Food and Drug Administration approved sotorasib (Lumakras...