FDA clears an Agfa 510(k) for the DR 800 multipurpose imaging system with tomosynthesis.
CDRH staffer Ribbi Shawar describes changes between the draft and final versions of a new guidance on coordinated development of antimicrobial drugs a...
FDA warns Chinas Hangzhou Sunking Nonwovens about CGMP violations in its manufacturing of finished pharmaceuticals.
FDA warns Indias Vipor Chemicals about CGMP deviations in its manufacturing of active pharmaceutical ingredients.
FDA places a partial clinical hold on a Xencor a Phase 1 study of XmAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients wi...
In a CDRH Webinar, associate director for digital health Bakul Patel explains the latest updates to the Centers pre-certification pilot program.
Federal Register notice: FDA classifies auto titration devices for oral appliances into Class 2 (special controls).
FDA approves Mercks Keytruda (pembrolizumab) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes following complete r...