Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and its use in treating H...
FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provides current agency sp...
FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, Japan.
FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to manage diabetes.
Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.
Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive sleep apnea into Cl...
CDER and CBER seek input to help advance the agencys model-informed drug development program.
FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently circulating variants...
