FDA approves a Rhythm Pharmaceutical NDA for Imcivree (setmelanotide) for chronic weight management in patients six years and older with obesity due t...
FDA launches the Innovative Science and Technology Approaches for New Drugs pilot program for novel drug development tool developers.
Moderna submits an emergency use authorization for its Covid-19 vaccine mRNA-1273 based on updated efficacy data showing 94.1% vaccine efficacy.
FDA approves a Profound Medical humanitarian device exemption to market Sonalleve for treating osteoid osteoma, a non-cancerous bone tumor in the leg.
FDA Review posts the Federal Register notices for the week ending 11/27/2020.
Federal Register notice: FDA posts a final guidance on its drug development tool qualification process.
Federal Register notice: FDA makes available a final guidance entitled Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA...