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PhRMA and BIO say that a PDUFA 5 program to improve transparency and communication in reviewing NDAs and BLAs with new molecular e...[ Price : $8.95]
FDA accepts for review a CardioFocus PMA for the HeartLight Endoscopic Ablation System for treating atrial fibrillation.[ Price : $8.95]
FDA announces drug safety changes for clozapine labeling involving monitoring for neutropenia and a new shared REMS.[ Price : $8.95]
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The Generic Pharmaceutical Association says that an FDA draft guidance on controlled correspondence is counter to provisions in th...