FDA accepts for review a Pfizer supplemental BLA for Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Abbotts Humira.
FDA sends Boise, ID-based Smart Surgical, dba Burst Biologics, a Warning Letter after an inspection last year determined it is marketing unapproved pr...
FDA clears a Teleflex expanded indication for its specialty catheters and coronary guidewires for use in crossing chronic total occlusion percutaneous...
FDA approves a Sage Chemical ANDA for the first generic version of Mylans Apokyn (apomorphine hydrochloride injection) drug cartridges to treat hypomo...
Speakers at a Friends of Cancer Research program on diagnostic tests push the VALID Act and the need for an FDA framework for regulating the tests.
FDA extends by three months its review of a Rhythm Pharmaceuticals supplemental NDA for Imcivree (setmelanotide) for treating obesity and control of h...
Federal Register notice: FDA seeks comments on an information collection extension entitled Exemptions From Substantial Equivalence Requirements for T...
FDA says GSK/Virs sotrovimab should not be used in geographic areas where Covid infection is likely to have been caused by a non-susceptible variant.