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Federal Register Notice: FDA withdraws two proposed rules published over five years ago because they are outdated.[ Price : $8.95]
Thermo Fisher Scientific files the final module of a PMA for its Oncomine Universal Dx Test, a multi-gene, next-generation sequenc...[ Price : $8.95]
FDA says it has amended its electronic submission Technical Rejection Criteria for Study Data to require study data standards in c...[ Price : $8.95]
FDA sends Dynavax Technologies a Complete Response Letter on its BLA for Heplisav-B [hepatitis B vaccine, recombinant (adjuvanted)...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an OMB submission to extend an information collection on the Reporting of Biologica...[ Price : $8.95]
Pennsylvania-based medical device manufacturer Biocompatibles pleads guilty to misbranding its embolic device LC Bead and will pay...[ Price : $8.95]
FDA approves a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic h...[ Price : $8.95]
FDA grants Seattle Genetics a breakthrough therapy designation for Adcetris (brentuximab vedotin) for treating patients with CD30-...