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Amicus Therapeutics says it plans to submit an NDA for migalastat for treating Fabry disease.[ Price : $8.95]
FDAs Vaccines and Related Biological Products Advisory Committee recommends accelerated approval for a NVS Influenza Vaccines BLA ...[ Price : $8.95]
FDA approves an Octapharma NDA for Nuwiq (antihemophilic factor-recombinant), indicated for treating adults and children living wi...[ Price : $8.95]
President Obama nominates FDA deputy commissioner for medical products and tobacco Robert M. Califf as the agencys next commission...[ Price : $8.95]
The Generic Pharmaceutical Association says that an FDA draft guidance on controlled correspondence is counter to provisions in th...[ Price : $8.95]
CDER issues a MAPP on the organization and work of the Centers Medical Policy Council.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Coram Healthcare Corp. of Indiana dba Coram CVS/Specialty Infusion Services, Jay...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection to the Office of Management and Budget on a guidance on Drug Supply Cha...