FDA approves an Otsuka Pharmaceutical and Lundbeck supplemental NDA for Rexulti (brexpriprazole) oral tablets for treating agitation associated with d...
Three stakeholder groups and seven individuals call for FDA to promptly approve a Knowledge Ecology International 2020 petition to ban music in DTC ad...
FDA commissioner Robert Califf and chief medical officer Hilary Marston describe ways the agency will be better able to address future public health e...
Federal Register notice: FDA releases a discussion paper entitled Using Artificial Intelligence (AI) and Machine Learning (ML) in the Development of D...
Federal Register notice: FDA determines that Roxane Laboratories hydrochlorothiazide oral solution was not withdrawn from sale due to safety or effect...
FDA clears a Sibel Health 510(k) on the ANNE One platform for continuous neonatal and infant monitoring.
FDA sends ImmunityBio a complete response letter on its BLA for Anktiva (N-803) in combination with Bacillus Calmette-Gurin (BCG) for treating certain...
Pharmaceutical Research and Manufacturers of America suggests things for FDA to consider as it moves forward from a March workshop on negative control...
