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Federal Register Notice: FDA announces the issuance of Emergency Use Authorizations for four in vitro diagnostic devices for detec...[ Price : $8.95]
FDA sends Regeneron Pharmaceuticals and Sanofi a Complete Response Letter on their BLA for sarilumab, an investigational interleuk...[ Price : $8.95]
HeartWare Inc. begins a Class 1 recall of its Ventricular Assist Device controller due to a loose power connector which may cause ...[ Price : $8.95]
FDA approves a Roche PMA for the Ventana PD-L1 (SP142) Assay as a complementary diagnostic to identify PD-L1 expression levels in ...[ Price : $8.95]
Adamas Pharmaceuticals files an NDA for ADS-5102 (amantadine hydrochloride) extended-release capsules, indicated for treating levo...[ Price : $8.95]
FDA clears a SeaSpine Holdings 510(k) for its Shoreline ACS Anterior Cervical Standalone System, which features TruProfile technol...[ Price : $8.95]
Salix asks FDA to require several specific test results for any ANDA citing any strength or indication of Xifaxan as the reference...[ Price : $8.95]
FDA publishes generic drug regulatory science priorities for FY 2017.