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).
The Trump Administration mulls FDA acting commissioner Ned Sharpless time at the agency, and without a nomination to move him into a permanent role hi...
A CDER Office of Prescription Drug Promotion Webinar discusses contents of a recent guidance on providing promotional labeling and advertising materia...
Federal Register notice: FDA extends the submission period related to a 6/29 notice on its drug Quality metrics feedback program.
Federal Register notice: FDA releases a final guidance on using placebos and allowing blinding in cancer clinical trials.
AstraZeneca says that the Phase 3 TULIP 2 trial for anifrolumab, an investigational drug for treating systemic lupus erythematosus, met its primary en...