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AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger pa...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plasti...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection revision entitled for Controlled Correspondence Related to G...[ Price : $8.95]
FDA revokes its orphan drug designation for Indiviors Sublocade because it was improperly granted.[ Price : $8.95]
FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.[ Price : $8.95]
CDRH regulatory advisor Joshua Silverstein tells a Webinar what changes were made to the final Special 510(k) guidance in response...[ Price : $8.95]
FDA grants EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies.[ Price : $8.95]
Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance.