AbbVie files a supplemental NDA for Imbruvica (ibrutinib) in combination with rituximab for the first-line treatment of younger patients with chronic ...
Federal Register notice: FDA withdraws approval of a Haemonetics ANDA for Anticoagulant Citrate Dextrose SolutionA, USP, in plastic bags.
Federal Register notice: FDA submits to OMB an information collection revision entitled for Controlled Correspondence Related to Generic Drug Developm...
FDA revokes its orphan drug designation for Indiviors Sublocade because it was improperly granted.
FDA approves changes to Baraclude labeling to report data from a post-marketing safety study.
FDA grants EIP Pharma a Fast Track designation for neflamapimod as a treatment for dementia with Lewy bodies.
Federal Register notice: FDA seeks comments on a draft document that details best practices for drug safety surveillance.
Michigan Sen. Gary Peters say he intends to investigate solutions to increasing drug prices and drug shortages.