Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.
FDA accepts for priority review an NS Pharma BLA for deramiocel, an investigational cell therapy for Duchenne muscular dystrophy cardiomyopathy.
FDA warns Elanco Animal Health that promotional materials for its Zenrelia are misbranded due to false and misleading representations about the canine...
An FDA safety alert says several manufacturers have recalled several lots of immune globulin intravenous and subcutaneous products due to a higher rat...
FDA warns Indias Shree Jaya Laboratories about CGMP deviations in its production of active pharmaceutical ingredients at a facility in Yadadri Bhuvana...
FDA warns Chinas Linghai ZhanWang Biotechnology Co. about CGMP violations in its manufacturing of over-the-counter drugs.
Pfizer and Arvinas announce positive topline results from a clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in certain adults w...
FDA tells Chinas Mid-Link Technology Testing Co. it is rejecting all data from all studies conducted by the company until it provides a substantive re...
