A new policy report urges sweeping FDA reforms, arguing that shortening the time required to bring drugs, biologics and medical devices to market coul...
FDA appoints Lisa Romano as principal deputy associate commissioner for inspections and investigations, elevating a 24-year agency veteran to one of t...
Fulcrum Therapeutics says it is discontinuing development of its lead sickle cell disease candidate, pociredir, after receiving feedback from FDA.The ...
FDA posts a draft guidance that proposes streamlined nonclinical safety testing approaches for certain oncology biologics and conjugated therapies.
ICH updates its long-running question-and-answer guidance tied to the ICH Q8, Q9 and Q10 pharmaceutical quality guidelines.
FDA issues BPI Labs a Form-483 following an April inspection for potential cross-contamination risks at its outsourcing facility in Largo, FL.
Replimune plans to resubmit its controversial BLA for RP1 (vusolimogene oderparepvec) in combination with Opdivo as a treatment for advanced melanoma ...
DexCom says it has identified two lots of stolen Dexcom G7 continuous glucose monitoring sensors that were diverted into the commercial market after b...
