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The International Council on Harmonization publishes the M12 final guideline on drug interactions and an accompanying question-and...[ Price : $8.95]
Federal Register notice: FDA issues an order permanently debarring Maria Anzures-Camarena from providing services related to an ap...[ Price : $8.95]
Federal Register notice: FDA withdraws three NDAs from multiple applicants after they notified the agency that the products were n...[ Price : $8.95]
FDA approves Amgens Bkemv as an interchangeable biosimilar for Alexions Soliris, indicated to treat two rare diseases.[ Price : $8.95]
Johnson & Johnson reports positive topline results from its pivotal Phase 3 MDD3001 clinical trial evaluating the efficacy and saf...[ Price : $8.95]
The American Clinical Laboratory Association and HealthTrackRX sue FDA to block the agencys final rule asserting authority over la...[ Price : $8.95]
FDA grants Eli Lilly accelerated approval for Retevmo (selpercatinib) for pediatric patients two years of age and older with advan...[ Price : $8.95]
Federal Register notice: FDA seeks comments on an OMB information collection extension entitled De Novo Classification Process (Ev...