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FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and olde...[ Price : $8.95]
FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool develope...[ Price : $8.95]
Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vac...[ Price : $8.95]
FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bo...[ Price : $8.95]
Federal Register notice: FDA orders the permanent debarment of Michael L. Babich from providing services in any capacity to a pers...[ Price : $8.95]
An FDA complete response letter tells Liquidia the agency needs more CMC data on the companys LIQ861 inhalation powder to treat pu...[ Price : $8.95]
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex ...