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 13 observations from an April inspection at Chinas Zhejiang Hushai Pharmaceutical Co.
The American Society of Health System Pharmacists says there were 227 active drug shortages in the second quarter of 2026, trending up for the third q...
Rep. Diana DeGette (D-CO) wins FDA assurances that several policy announcements issued during former commissioner Marty Makary's tenure including art...
