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Sens. Grassley and Warren ask FDA to promptly issue its proposed rule on OTC hearing aids.[ Price : $8.95]
A petition submitted for an unnamed client asks FDA not to approve roxadustat for treating anemia in patients with chronic kidney ...[ Price : $8.95]
Stakeholders suggest changes to an FDA draft guidance on including geriatric information in drug labeling.[ Price : $8.95]
In its second biennial report required by the 21st Century Cures Act, FDA says that software not considered a medical device gener...[ Price : $8.95]
FDA says it will review the Samsung Bioepsis/Biogen BLA for a biosimilar of Genentechs Lucentis.[ Price : $8.95]
Omeros completes a rolling BLA submission for narsoplimab for treating hematopoietic stem cell transplant-associated thrombotic mi...[ Price : $8.95]
FDA delays the PDUFA action date to complete review of a BMS BLA for liso-cel to treat some large B-cell lymphomas due to the pand...[ Price : $8.95]
FDA grants Lucira Health an Emergency Use Authorization for the first prescription molecular diagnostic test for Covid-19 that can...