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FDA releases a summary of changes to seven REMS shown on the REMS Web site in July and August.[ Price : $8.95]
Novartis says it will file a BLA and seek other global approvals for its leukemia drug Arzerra (ofatumumab) and its use in treatin...[ Price : $8.95]
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Device Good Manufacturing Practice Advisory...[ Price : $8.95]
Federal Register notice: FDA corrects the docket number in a 12/2017 notice entitled Pediatric Rare Diseases--A Collaborative Appr...[ Price : $8.95]
Federal Register notice: FDA seeks comments on nine bulk drug substances that it is proposing not to allow outsourcing facilities ...[ Price : $8.95]
FDA grants Concept Medical a breakthrough device designation for MagicTouch AVF, a sirolimus drug-coated balloon catheter for trea...[ Price : $8.95]
FDA grants Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplanta...[ Price : $8.95]
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Puma Bios Nerlynx (neratini...