Federal Register notice: FDA publishes a list of 18 information collections that have been approved by OMB.
FDA approves a Foundation Medicine PMA for its FoundationOne CDx to be used as a companion diagnostic for Eli Lillys Retevmo (selpercatinib).
FDA sends Alnylam Pharmaceuticals a complete response letter on a supplemental NDA for Onpattro (patisiran) for treating cardiomyopathy of transthyret...
FDA issues Biocon Biologics a complete response letter on its BLA for insulin aspart.
FDA grants ZKR Orthopedics a breakthrough device designation for its Lift implant technology, which is designed to delay or eliminate the need for kne...
Federal Register notice: FDA withdraws 11 ANDAs from Dr. Reddys Laboratories after the company requested the actions because the products are no longe...
FDA grants HistoSonics a de novo marketing authorization for the Edison System, which the company says uses focused sound energy to mechanically destr...
AstraZeneca urges FDA to provide more detailed guidance or recommendations on how early in the drug development process sponsors should start to colle...
