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FDA issues Emergent BioSolutions an 8/10 Warning Letter after a February inspection cites GMP issues at its Camden, MD manufacturi...[ Price : $8.95]
French national and Hexim Pharmaceuticals chief executive officer Alain Bouaziz pleads guilty to making false statements to FDA to...[ Price : $8.95]
Gilead Sciences files a sBLA for Trodelvy (sacituzumab govitecan-hziy), seeking expanded approval in patients with HR+/HER2- metas...[ Price : $8.95]
Medtronic recalls its Cobalt and Crome implantable cardioverter defibrillators because the devices have the potential for reduced ...[ Price : $8.95]
FDA clears a Dyad Medical 510(k) for its echocardiogram application called Echo:Prio.[ Price : $8.95]
Weeks after being administered a Novartis gene therapy, two children die of acute liver failure, according to the company.[ Price : $8.95]
Federal Register notice: FDA sends to OMB an information collection extension entitled Agreement for Shipment of Devices for Steri...[ Price : $8.95]
FDA posts nine guidances released by the International Cooperation on Harmonization of Technical Requirements for Registration of ...