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An FDA advisory panel rejects a Medtronic PMA for its Phased RF Ablation System.[ Price : $8.95]
Dynavax Technologies says FDA has concurred with its plans to file a BLA early in 2012 on its Heplisav hepatitis B vaccine for per...[ Price : $8.95]
FDA approves a Medtronic IDE to conduct a pivotal in-home clinical trial for the ASPIRE study involving the MiniMed Paradigm Syste...[ Price : $8.95]
FDA grants 510(k) clearance to Spinal USA for Vault Stand Alone ALIF System for intervertebral body fusion of the spine in patient...[ Price : $8.95]
FDA grants Biovest International an orphan drug designation for BiovaxID for treating Waldenstrom's macroglobulinemia.[ Price : $8.95]
Gilead Sciences files an NDA for Quad, a single-tablet regimen of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil...[ Price : $8.95]
FDA says fewer NDA/ANDA bioanalytical studies will need to be repeated or confirmed based on earlier data integrity concerns at co...[ Price : $8.95]
FDA approves an Abbott supplemental NDA for Lupron Depot-PED (leuprolide acetate for depot suspension) to include long-term data i...