FDA cites Fujifilm Diosynth Biotechnologies USA for significant manufacturing deficiencies at its drug substance facility in Research Triangle Park, N...
FDA accepts for review a Camurus NDA resubmission for Oclaiz (octreotide), a long-acting injection for treating acromegaly.
Bolton Medical recalls its Relay Pro Thoracic Stent Graft Systems due to reports of a deployment failure that may result in serious injury or death.
FDA issues a Form-483 to Charles River Laboratories' Endosafe contract testing laboratory in Charleston, SC, over multiple quality system deficiencies...
A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the limitations of FDA accelerated approvals when disc...
FDA releases the form FDA-483 with five observations from an inspection at Icelands Alvotech EF.
MassDevice reports a Minnesota federal judge gave significant victories to Medtronic and FDA in four cases involving the companys spinal cord stimulat...
FDA publishes the latest CDER guidance agenda showing plans for 85 new or revised guidances to be issued in 2026.
