FDA Review posts product approval summaries for the week ending 8/30/2019.
Novartis says it will file a BLA and seek other global approvals for its leukemia drug Arzerra (ofatumumab) and its use in treating relapsing forms of...
Federal Register notice: FDA requests nominations for voting members to serve on CDRHs Device Good Manufacturing Practice Advisory Committee and the M...
Federal Register notice: FDA corrects the docket number in a 12/2017 notice entitled Pediatric Rare Diseases--A Collaborative Approach for Drug Develo...
Federal Register notice: FDA seeks comments on nine bulk drug substances that it is proposing not to allow outsourcing facilities to use in drug compo...
FDA grants Concept Medical a breakthrough device designation for MagicTouch AVF, a sirolimus drug-coated balloon catheter for treating stenotic lesion...
FDA grants Akari Therapeutics an orphan drug designation for nomacopan and its use in treating hematopoietic stem cell transplantation-associated thro...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Puma Bios Nerlynx (neratinib).