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FDA releases its latest batch of Warning Letters that includes Hubei Danjiangkou Danao Pharmaceutical and Vita-Pure.[ Price : $8.95]
FDA commissioner Scott Gottlieb says the agency has issued a new guidance and taken other steps to help sponsors test and seek app...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for 513(g) Request for Information OMB Control ...[ Price : $8.95]
Cytokinetics suspends its tirasemtiv drug development program after receiving disappointing data from the VITALITY-ALS Phase 3 cli...[ Price : $8.95]
Federal Register notice: FDA determines that Takedas Trintellix (vortioxetine hydrobromide) oral tablet, indicated for treating ma...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for its guidance on Notification of the Intent ...[ Price : $8.95]
FDA approves a ViiV Healthcare NDA for Juluca, the first complete treatment regimen containing two drugs to treat certain adults w...[ Price : $8.95]
Stakeholders ask FDA for greater clarification on elements in its proposed framework for drug benefit-risk analysis.