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FDA releases a final guidance entitled Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbi...[ Price : $8.95]
FDA denies a petition seeking Risk Evaluation and Mitigation Strategiesfor Behrings simultaneously approved Hemophilia B gene ther...[ Price : $8.95]
CDRH qualifies the CHemical RISk calculator Color Additives under its Medical Device Development Tools program.[ Price : $8.95]
The journal Science says safety questions are being raised about Eisai and Biogens lecanemab (BAN2401), an investigational anti-am...[ Price : $8.95]
FDA sends Spectrum Pharmaceuticals a complete response letter rejecting the companys poziotinib and its use in treating certain pa...[ Price : $8.95]
Federal Register notice: FDA announces a 1/9 Dermatologic and Ophthalmic Drugs Advisory Committee meeting to discuss a Regeneron P...[ Price : $8.95]
FDA approves an emergency use authorization for the Lucira Covid-19 and Flu Test.[ Price : $8.95]
Federal Register notice: FDA announces that a priority review voucher was redeemed 6/16 by AbbVie for a supplemental BLA for Skyri...