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Federal Register notice: FDA announces its implementation of a court decision that ruled the agency is not afforded discretion whe...[ Price : $8.95]
Federal Register notice: FDA extends the period for states to decide whether to sign the final standard memorandum of understandin...[ Price : $8.95]
FDA sends Spectrum Pharmaceuticals a complete response letter on its BLA for Rolontis (eflapegrastim), citing deficiencies related...[ Price : $8.95]
Boston Scientific begins enrolling in the HI-PEITHO clinical trial to compare its EkoSonic Endovascular System in combination with...[ Price : $8.95]
Researchers call on FDA to reconsider class suicide risk warnings for all epilepsy drugs.[ Price : $8.95]
FDA grants Apexigen an orphan drug designation for APX005M (sotigalimab) for treating soft tissue sarcoma.[ Price : $8.95]
Three FDA officials say the recent approval of Astellas Prograf for a new indication demonstrates that real-world data observation...[ Price : $8.95]
An FDA complete response letter says an Ardelyx NDA for tenapanor did not show sufficient treatment effect to be approved.