FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted bronchoscopy.
Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.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...
Merck says it will seek FDA approval for new HIV regimen following its announcement of positive results from two pivotal Phase 3 trials of doravirine/...
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.
