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CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.[ Price : $8.95]
FDA approval numbers show it approved 23 novel drugs during the first six months of 2026, maintaining a pace that would be consist...[ Price : $8.95]
FDA sends Ascelia Pharma a Complete Response Letter regarding its NDA for Orviglance, a contrast agent for liver imaging.[ Price : $8.95]
FDA warns Chinas BMC Medical that it is marketing adulterated and misbranded ventilators in the U.S. without an approved PMA in pl...[ Price : $8.95]
FDA approves an expanded age indication for Vertex Pharmaceuticals sickle cell drug Casgevy.[ Price : $8.95]
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FDA warns AseptiKits it is manufacturing and marketing adulterated and misbranded PALA Your Tears medical devices.[ Price : $8.95]
FDA approves PharmaEssentias BESREMi injection pen to treat polycythemia vera.