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Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.[ Price : $8.95]
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selp...[ Price : $8.95]
FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyo...[ Price : $8.95]
FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.[ Price : $8.95]
FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or elimin...[ Price : $8.95]
Federal Register notice: FDA withdraws 11 ANDAs from Dr. Reddys Laboratories after the company requested the actions because the p...[ Price : $8.95]
FDA grants HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy t...[ Price : $8.95]
AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors s...